67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151

  
100 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05373264
(ClinicalTrials.gov)
February 202328/4/2022HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of LifeHYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of LifeADPKDDrug: Hydrochlorothiazide 25 mg;Drug: PlaceboUniversity Medical Center GroningenNULLNot yet recruiting18 Years80 YearsAll300Phase 3Belgium;France;Germany;Netherlands;Spain;United Kingdom;United States
2NCT04939935
(ClinicalTrials.gov)
November 202216/6/2021Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled TrialAutosomal Dominant Polycystic Kidney DiseaseDrug: Metformin XR;Other: ControlThe University of QueenslandNULLNot yet recruiting18 Years70 YearsAll1164Phase 3Australia
3NCT05510115
(ClinicalTrials.gov)
October 17, 202211/8/2022Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney DiseaseFeasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: Empagliflozin;Drug: PlaceboUniversity of Colorado, DenverUniversity of MarylandNot yet recruiting18 Years50 YearsAll50Phase 2United States
4NCT05521191
(ClinicalTrials.gov)
October 6, 202224/8/2022A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney DiseaseA Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Patients With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429Autosomal Dominant Polycystic Kidney Disease;ADPKD;Polycystic Kidney, Autosomal DominantDrug: RGLS8429;Drug: PlaceboRegulus Therapeutics Inc.NULLRecruiting18 Years70 YearsAll36Phase 1United States
5NCT05401409
(ClinicalTrials.gov)
May 5, 202227/5/2022Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney DiseaseDouble-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;Hypertension;Endothelial DysfunctionDietary Supplement: Beetroot juice;Dietary Supplement: Nitrate-depleted beetroot juiceWestern Sydney Local Health DistrictWestmead Institute for Medical ResearchRecruiting18 Years70 YearsAll60N/AAustralia
6NCT05228574
(ClinicalTrials.gov)
March 11, 202212/1/2022Treatment of Vascular Stiffness in ADPKDTreatment of Vascular Stiffness in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyDietary Supplement: Sodium chloride (NaCl);Dietary Supplement: Placebo;Drug: Amiloride Hcl 5mg TabErasmus Medical CenterNULLRecruiting18 YearsN/AAll54Phase 4Netherlands
7EUCTR2021-003062-12-SK
(EUCTR)
11/03/202216/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
8EUCTR2021-003062-12-PL
(EUCTR)
24/02/202223/11/2021A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Israel;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Georgia;Bulgaria
9EUCTR2021-003062-12-BG
(EUCTR)
09/02/202206/12/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3Serbia;United States;Portugal;Slovakia;Spain;Ukraine;Israel;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
10EUCTR2021-003062-12-ES
(EUCTR)
21/01/202220/10/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
11EUCTR2021-003062-12-IT
(EUCTR)
20/01/202218/10/2021A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: [0C23]
INN or Proposed INN: Lixivaptan
Palladio Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
12EUCTR2021-003062-12-HU
(EUCTR)
03/01/202205/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
13NCT04064346
(ClinicalTrials.gov)
October 28, 202119/8/2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase: The ACTION StudyAutosomal Dominant Polycystic Kidney;ADPKDDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesCentessa Pharmaceuticals plcTerminated18 Years60 YearsAll12Phase 3United States;Australia;Bulgaria;Hungary;Poland;Spain;Turkey;United Kingdom;Argentina;Canada;Chile;Israel;Italy;Mexico;Romania;Slovakia
14NCT04908462
(ClinicalTrials.gov)
June 8, 202118/5/2021To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy VolunteersA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211Autosomal Dominant Polycystic KidneyDrug: AL01211 or Placebo (Part A);Drug: AL01211 or Placebo (Part B)AceLink Therapeutics, Inc.Novotech (Australia) Pty LimitedCompleted18 Years55 YearsAll69Phase 1Australia
15NCT04578548
(ClinicalTrials.gov)
November 10, 20201/10/2020A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Placebo;Drug: GLPG2737Galapagos NVNULLActive, not recruiting18 Years50 YearsAll66Phase 2Belgium;Czechia;Germany;Italy;Netherlands;Poland;Spain
16EUCTR2019-003521-21-CZ
(EUCTR)
14/10/202028/07/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenterstudy to evaluate the efficacy, safety, tolerability and pharmacokinetics oforally administered GLPG2737 for 52 weeks, followed by an open-labelextension period of 52 weeks in subjects with autosomal dominantpolycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
17EUCTR2019-003521-21-DE
(EUCTR)
14/09/202010/03/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Netherlands;Germany;Italy
18NCT04310319
(ClinicalTrials.gov)
September 7, 20203/3/2020Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltWishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltPolycystic Kidney, Autosomal Dominant;ADPKD;Autosomal Dominant Polycystic KidneyDietary Supplement: Sodiumchloride;Dietary Supplement: Protein;Dietary Supplement: Placebo comparator (salt);Dietary Supplement: Placebo comparator (protein)Esther MeijerNULLRecruiting18 YearsN/AAll12N/ANetherlands
19EUCTR2019-003521-21-IT
(EUCTR)
22/07/202011/01/2021A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease - A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney di Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: [G1117337]
Other descriptive name: GLPG2737
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Greece;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy
20EUCTR2019-003521-21-NL
(EUCTR)
18/03/202007/11/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
21EUCTR2019-003521-21-BE
(EUCTR)
20/01/202024/10/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
22NCT03918447
(ClinicalTrials.gov)
May 29, 201912/4/2019A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCONA Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsuleReata Pharmaceuticals, Inc.NULLRecruiting12 Years70 YearsAll850Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom
23EUCTR2017-004084-12-AT
(EUCTR)
11/04/201914/01/2019A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
24EUCTR2017-004084-12-RO
(EUCTR)
25/03/201923/05/2022Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
836Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Belgium;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
25EUCTR2017-004084-12-NL
(EUCTR)
13/02/201906/06/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
26JPRN-JapicCTI-184192
31/1/201905/11/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients.Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) Polycystic kidney, autosomal dominantIntervention name : GZ402671
INN of the intervention : venglustat
Dosage And administration of the intervention : once daily for 24 months
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : once daily for 24 months
Sanofi K.K.NULLother1855BOTH640Phase 2-3Japan, Asia except Japan, North America, South America, Europe, Oceania
27EUCTR2017-004084-12-GB
(EUCTR)
28/01/201924/05/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
28NCT03541447
(ClinicalTrials.gov)
December 12, 201817/5/2018Tolvaptan-Octreotide LAR Combination in ADPKDA Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or HyperfiltrationAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: Octreotide LAR;Other: PlaceboMario Negri Institute for Pharmacological ResearchOtsuka Pharmaceutical Italy S.r.l.Completed18 YearsN/AAll20Phase 2Italy
29EUCTR2017-004084-12-DK
(EUCTR)
07/11/201823/05/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
30NCT03523728
(ClinicalTrials.gov)
October 4, 20181/5/2018A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: Venglustat;Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 Years55 YearsAll478Phase 2/Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Spain;Taiwan;Turkey;United Kingdom
31EUCTR2017-004084-12-BE
(EUCTR)
31/08/201831/05/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
32EUCTR2017-004701-40-IT
(EUCTR)
06/08/201826/09/2019 STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD Autosomal Dominant Policiytic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI
Product Name: sandostatina LAR
Product Code: sandostatina
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
33EUCTR2017-004084-12-PT
(EUCTR)
06/08/201811/06/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
34EUCTR2017-004084-12-IT
(EUCTR)
12/07/201817/06/2021Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
GENZYME CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
35EUCTR2017-004084-12-DE
(EUCTR)
10/07/201822/05/2018A Medical Research Study Designed to Determine if Venglustat can be aFuture Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
36EUCTR2017-004084-12-CZ
(EUCTR)
03/07/201813/06/2018A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
37EUCTR2017-004084-12-ES
(EUCTR)
05/06/201806/06/2018Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
836 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
38NCT03203642
(ClinicalTrials.gov)
October 12, 201726/6/2017Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKDA Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Tesevatinib;Drug: PlaceboKadmon, a Sanofi CompanyNULLCompleted18 Years60 YearsAll80Phase 2United States
39NCT03273413
(ClinicalTrials.gov)
August 31, 20171/9/2017Statin Therapy in Patients With Early Stage ADPKDStatin Therapy in Patients With Early Stage ADPKDADPKD;Autosomal Dominant Polycystic KidneyDrug: Pravastatin;Drug: PlaceboUniversity of Colorado, DenverNULLActive, not recruiting25 Years60 YearsAll150Phase 4United States
40NCT02903511
(ClinicalTrials.gov)
November 201613/9/2016Feasibility Study of Metformin Therapy in ADPKDFeasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.Polycystic Kidney, Autosomal DominantDrug: Metformin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed30 Years60 YearsAll56Phase 2United States
41EUCTR2016-000187-42-GB
(EUCTR)
24/10/201606/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Belgium;Germany;Italy;United Kingdom
42EUCTR2016-000187-42-DE
(EUCTR)
13/10/201610/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Belgium;Germany;United Kingdom;Italy
43EUCTR2016-000187-42-IT
(EUCTR)
26/09/201612/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy
44NCT02964273
(ClinicalTrials.gov)
September 23, 201615/9/2016Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Tolvaptan;Drug: Tolvaptan Matching-placeboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted4 Years17 YearsAll91Phase 3Belgium;Germany;Italy;United Kingdom
45EUCTR2016-000187-42-BE
(EUCTR)
24/08/201624/05/2016A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Belgium;Germany;United Kingdom;Italy
46NCT02697617
(ClinicalTrials.gov)
January 26, 201630/10/2015Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney DiseaseUse of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic KidneyPolycystic Kidney DiseaseDrug: Pioglitazone;Drug: PlaceboIndiana UniversityNULLActive, not recruiting18 Years55 YearsAll18Phase 2United States
47NCT03803124
(ClinicalTrials.gov)
December 20157/1/2019Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDEffect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDPolycystic Kidney, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroNULLCompleted18 YearsN/AAll20Phase 3Denmark
48NCT02494141
(ClinicalTrials.gov)
November 12, 201525/6/2015Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDCurcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDPolycystic Kidney, Autosomal DominantDrug: Curcumin;Other: PlaceboUniversity of Colorado, DenverNULLCompleted6 Years25 YearsAll68Phase 4United States
49EUCTR2014-000226-38-FR
(EUCTR)
16/10/201511/12/2015This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
50NCT02558595
(ClinicalTrials.gov)
September 22, 201521/9/2015Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: Niacinamide;Other: PlaceboUniversity of Kansas Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll36Phase 2United States
51EUCTR2014-000226-38-PL
(EUCTR)
10/03/201508/12/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Sweden
52NCT02527863
(ClinicalTrials.gov)
February 201518/2/2015Effect of the Aquaretic Tolvaptan on Nitric Oxide SystemThe Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroAarhus University HospitalCompleted18 Years65 YearsAll18Phase 2Denmark
53EUCTR2014-000226-38-CZ
(EUCTR)
21/01/201513/11/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
54EUCTR2014-000226-38-GB
(EUCTR)
08/01/201531/07/2014 This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot Recruiting Female: yes
Male: yes
1300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
55EUCTR2014-000226-38-ES
(EUCTR)
02/01/201516/10/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
56EUCTR2014-000226-38-NL
(EUCTR)
22/12/201424/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
57EUCTR2014-000226-38-BE
(EUCTR)
17/12/201426/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
58EUCTR2014-000226-38-DK
(EUCTR)
02/12/201411/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
59EUCTR2014-000226-38-SE
(EUCTR)
21/11/201414/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
60EUCTR2014-000226-38-IT
(EUCTR)
11/11/201405/08/2014A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
61EUCTR2014-000226-38-HU
(EUCTR)
03/11/201421/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
62NCT02160145
(ClinicalTrials.gov)
May 20146/6/2014Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseChronic Kidney Disease;Autosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan (OPC-41061);Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years65 YearsAll1370Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic
63NCT02115659
(ClinicalTrials.gov)
April 201414/4/2014Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Triptolide-Containing Formulation;Drug: PlaceboShanghai Changzheng HospitalNULLRecruiting40 Years75 YearsBoth100Phase 3China
64NCT02055079
(ClinicalTrials.gov)
April 201431/1/2014Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney DiseasePulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP StudyPolycystic Kidney, Type 1 Autosomal Dominant Disease;Polycystic Kidney, Type 2 Autosomal Dominant DiseaseDrug: Sirolimus;Drug: PlaceboMedical University of ViennaNULLUnknown status18 YearsN/AAll68Phase 3Austria
65NCT01670110
(ClinicalTrials.gov)
August 201217/8/2012Pasireotide LAR in Severe Polycystic Liver DiseaseA Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver DiseaseSomatostatin Analogs;Polycystic Liver Disease;Autosomal Dominant Polycystic Kidney Disease;Autosomal Dominant Polycystic Liver DiseaseDrug: Pasireotide LAR;Drug: PlaceboMayo ClinicNULLCompleted18 Years100 YearsAll48Phase 2United States
66EUCTR2010-023017-65-BG
(EUCTR)
14/05/201222/05/2012A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
67EUCTR2010-023017-65-LT
(EUCTR)
14/11/201102/09/2011A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
68EUCTR2010-023017-65-IT
(EUCTR)
28/10/201114/03/2012A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: BOSUTINIB
Other descriptive name: SKI-606
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden
69NCT01451827
(ClinicalTrials.gov)
October 201111/10/20118-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IR;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll178Phase 2United States
70EUCTR2010-023017-65-GB
(EUCTR)
02/08/201108/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
275 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden
71EUCTR2010-023017-65-CZ
(EUCTR)
16/06/201101/02/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden
72EUCTR2010-023017-65-HU
(EUCTR)
27/05/201105/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden
73EUCTR2010-023017-65-SK
(EUCTR)
25/05/201128/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
74NCT01377246
(ClinicalTrials.gov)
May 201120/6/2011Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal InsufficiencyA PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCYAutosomal Dominant Polycystic Kidney DiseaseDrug: Octreotide-LAR;Other: Saline solution.Mario Negri Institute for Pharmacological ResearchNULLCompleted18 Years75 YearsAll100Phase 3Italy
75EUCTR2010-023017-65-PL
(EUCTR)
21/04/201112/04/2011A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden
76EUCTR2011-000138-12-IT
(EUCTR)
04/04/201128/12/2011A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: SANDOSTATINA LAR
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
77EUCTR2010-023017-65-ES
(EUCTR)
18/03/201127/01/2011ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). Poliquistosis renal autosómica dominante (PRAD).
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
PFIZER, S.L.U.NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
78EUCTR2010-023017-65-SE
(EUCTR)
17/03/201120/01/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
79NCT01233869
(ClinicalTrials.gov)
December 201028/10/2010Bosutinib For Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: Bosutinib;Drug: PlaceboPfizerNULLCompleted18 Years50 YearsAll172Phase 2United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
80NCT01210560
(ClinicalTrials.gov)
October 201021/9/2010Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKDA Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IROtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll25Phase 2United States
81NCT00920309
(ClinicalTrials.gov)
June 200912/6/2009Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to TherapyRapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to TherapyAutosomal Dominant Polycystic Kidney DiseaseDrug: Rapamycin;Other: Standard of Care-PlaceboYale UniversityNULLTerminated18 Years70 YearsAll21Phase 2/Phase 3United States
82NCT02119013
(ClinicalTrials.gov)
January 200917/4/2014Effects of Somatostatin on ADPKD HeartEFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDYAutosomal Dominant Polycystic Kidney Disease;Glomerular Filtration Rate > 40 ml/MinDrug: Octeotride;Drug: PlaceboFederico II UniversityNULLCompleted18 Years80 YearsBoth35Phase 2/Phase 3NULL
83NCT02119052
(ClinicalTrials.gov)
January 200917/4/2014Effects of Somatostatin on Liver in ADPKDEffect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: octeotride;Drug: placeboFederico II UniversityNULLCompleted18 YearsN/ABoth35Phase 2/Phase 3NULL
84NCT00565097
(ClinicalTrials.gov)
October 200728/11/2007Lanreotide as Treatment of Polycystic LiversLong-Acting Lanreotide as a Volume Reducing Treatment of Polycystic LiversPolycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney, Autosomal DominantDrug: Placebo;Drug: LanreotideRadboud UniversityIpsenCompleted18 Years88 YearsBoth38Phase 2/Phase 3Belgium;Netherlands
85EUCTR2006-001485-16-FR
(EUCTR)
20/08/200723/07/2007A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
86EUCTR2006-002768-24-DE
(EUCTR)
03/05/200715/12/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;Italy;United Kingdom
87EUCTR2006-002768-24-GB
(EUCTR)
23/04/200707/12/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Denmark;Germany;Italy;United Kingdom
88EUCTR2006-002768-24-FR
(EUCTR)
18/04/200729/12/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Denmark;Germany;Italy;United Kingdom
89EUCTR2006-002768-24-BE
(EUCTR)
26/03/200705/12/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization. Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Denmark;Germany;Italy;United Kingdom
90EUCTR2006-002768-24-DK
(EUCTR)
26/01/200729/11/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - -A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;Italy;United Kingdom
91JPRN-JapicCTI-070402
25/1/200721/05/2007Tolvaptan efficacy and safety in management of polycystic kidney desease and its outcomes (TEMPO3/4)A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan regimens in adult subjects with autosomal dominant polycystic kidney disease (ADPKD) Autosomal dominant polycystic kidney disease (ADPKD)Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 45/15 mg
Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 60/30 mg
Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 90/30 mg
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Oral
Otsuka Pharmaceutical Co., Ltd.NULLcomplete2050BOTH1500Phase 3Japan, North America, South America, Europe, Oceania
92NCT00428948
(ClinicalTrials.gov)
January 200726/1/2007Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney Disease, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 Years50 YearsAll1445Phase 3United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom
93NCT00426153
(ClinicalTrials.gov)
January 200722/1/2007Octreotide in Severe Polycystic Liver DiseasePilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver DiseasePolycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal PainDrug: Octreotide;Drug: PlaceboMayo ClinicNovartis;National Center for Research Resources (NCRR)Completed18 Years80 YearsAll42Phase 2/Phase 3United States
94EUCTR2006-001485-16-AT
(EUCTR)
15/12/200616/11/2006A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican Tabletten
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
95NCT00414440
(ClinicalTrials.gov)
December 200620/12/2006Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney DiseaseA Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney DiseaseDrug: Placebo;Drug: EverolimusNovartis PharmaceuticalsNULLCompleted18 Years50 YearsAll431Phase 4Austria;France;Germany
96NCT00456365
(ClinicalTrials.gov)
November 200612/3/2007Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: pravastatin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed8 Years22 YearsAll110Phase 3United States
97EUCTR2006-001485-16-DE
(EUCTR)
25/10/200619/01/2007A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican Tabletten
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
98NCT00283686
(ClinicalTrials.gov)
January 200626/1/2006HALT Progression of Polycystic Kidney Disease Study AHALT Progression of Polycystic Kidney Disease Study AKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: Placebo;Other: Standard Blood Pressure Control;Other: Low Blood Pressure ControlNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of MedicineCompleted15 Years64 YearsAll558Phase 3United States
99NCT01885559
(ClinicalTrials.gov)
January 200617/6/2013HALT Progression of Polycystic Kidney Disease Study BHALT Progression of Polycystic Kidney Disease Study BKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of MedicineCompleted15 Years64 YearsAll486Phase 3United States
100EUCTR2019-003521-21-ES
(EUCTR)
28/05/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Belgium;Spain;Germany;Netherlands;Italy