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 67. Polycystic kidney
 [ 99 clinical trials,    110 drugs(DrugBank: 42 drugs),    28 target genes / 133 target pathways

Searched query = "Polycystic kidney"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

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1NCT04064346March 20209 September 2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA 52-Week, Phase 3, Double-blind, Placebo-controlled, Randomized Study of the Efficacy and Safety of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney Disease, AdultDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesNot recruiting18 Years60 YearsAll1200Phase 3
2NCT04152837February 202011 November 2019Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney DiseaseA Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Experienced Liver Function Test Abnormalities While Receiving TolvaptanPolycystic Kidney Disease, AdultDrug: LixivaptanPalladio BiosciencesNot recruiting18 Years65 YearsAll50Phase 3
3NCT03949894June 20, 20194 November 2019Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseEvaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.Recruiting19 Years50 YearsAll100Phase 4Korea, Republic of
4NCT03918447May 29, 20199 September 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.Recruiting18 Years70 YearsAll300Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Spain;United Kingdom
5NCT03717181May 22, 201922 July 2019Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseaseExpanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseasePolycystic KidneyDrug: LixivaptanPalladio BiosciencesRecruiting15 Years60 YearsAll1Phase 2United States
No.TrialIDDate_
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6JPRN-jRCTs03118025901/04/201910 September 2019Tolvaptan Intervention study and Genetic mutation of Autosomal Dominant Polycystic Kidney DiseaseTolvaptan Intervention study to Autosomal Dominant Polycystic Kidney Disease patients without Genetic mutation of disease gene - TIAGADPKDTolvaptan treatmentShigeo HorieRecruiting20 yearNot applicableBoth10N/ANone
7EUCTR2017-004084-12-NL13/02/201928 February 2019Study 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-PKDCongenital, 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
Pharmaceutical Form: Capsule
INN or Proposed INN: Venglustat
CAS Number: 1401090-53-6
Current Sponsor code: GZ/SAR402671
Other descriptive name: Genz-682452-AU
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
Pharmaceutical Form: Capsule
INN or Proposed INN: Venglustat
CAS Number: 1401090-53-6
Current Sponsor code: GZ/SAR402671
Other descriptive name: Genz-682452-AU
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Genzyme CorporationAuthorised Female: yes
Male: yes
836Phase 2Portugal;United States;Taiwan;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of
8JPRN-JapicCTI-18419231/1/201916 July 2019A 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.Recruiting1850BOTH560Phase 2-3Japan, Asia except Japan, North America, Europe
9NCT03764605January 30, 201918 December 2018Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney DiseaseMetformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled TrialADPKDDrug: Metformin;Drug: TolvaptanAzienda Ospedaliero-Universitaria ConsorzialeNot recruiting18 Years50 YearsAll150Phase 3Italy
10NCT03541447December 12, 201815 July 2019Tolvaptan-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.Recruiting18 YearsN/AAll20Phase 2Italy
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11NCT03687554October 5, 201825 March 2019Effect of Venglustat in Patients With Renal ImpairmentA Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal FunctionHealthy Volunteers;Polycystic Kidney, Autosomal DominantDrug: Venglustat GZ/SAR402671Genzyme, a Sanofi CompanyNot recruiting18 Years79 YearsAll24Phase 1United States
12NCT03523728October 4, 201828 October 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)Polycystic Kidney, Autosomal DominantDrug: Placebo;Drug: Venglustat GZ402671Genzyme, a Sanofi CompanyRecruiting18 Years50 YearsAll560Phase 2/Phase 3United States;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Spain;Taiwan;United Kingdom
13NCT03487913September 14, 20184 November 2019The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: LixivaptanPalladio BiosciencesRecruiting18 Years65 YearsAll32Phase 2United States
14NCT03596957September 12, 20183 December 2018Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseSubacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyDrug: TolvaptanLisbet BrandiRecruiting18 Years65 YearsAll90Phase 4Denmark
15EUCTR2017-003864-10-NL02/05/20185 June 2018Medication for excessive urine production in patients treated with tolvaptanHydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptanAutosomal dominant polycystic kidney disease;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Hydrochlorothiazide
Product Code: HCT
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Metformin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University Medical Center GroningenAuthorisedFemale: yes
Male: yes
12Phase 2Netherlands
No.TrialIDDate_
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16NCT03423810April 23, 20188 April 2019Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsAssessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsPolycystic Kidney DiseasesDrug: HydralazineUniversity of Kansas Medical CenterRecruiting18 Years65 YearsAll10Early Phase 1United States
17EUCTR2017-004115-39-DK08/02/20185 March 2018Same as aboveSubacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DIsease
MedDRA version: 20.0 Level: LLT Classification code 10036045 Term: Polycystic kidney System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 15 or 45 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 15-45
Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 60 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 30-60
Trade Name: Jinarc 30 mg tablets, 90 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 90 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 30-90
Nordsjællands Hospital, Department of Cardiology, Nephrology and EndocrinologyAuthorisedFemale: yes
Male: yes
90Phase 4Denmark
18NCT03366337December 26, 201724 June 2019A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXA Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney DiseasesIgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.Not recruiting18 Years65 YearsAll103Phase 2United States
19NCT03273413August 31, 20174 November 2019Statin Therapy in Patients With Early Stage ADPKDStatin Therapy in Patients With Early Stage ADPKDADPKD;Autosomal Dominant Polycystic KidneyDrug: Pravastatin;Drug: PlaceboUniversity of Colorado, DenverRecruiting25 Years60 YearsAll200Phase 4United States
20NCT03203642August 9, 201711 November 2019Study 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 Corporation, LLCRecruiting18 Years60 YearsAll100Phase 2United States
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21NCT03096080June 14, 201711 November 2019A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 1, Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)Polycystic Kidney, Autosomal RecessiveDrug: TesevatinibKadmon Corporation, LLCNot recruiting5 Years12 YearsAll10Phase 1United States
22NCT03102632June 1, 201717 June 2019A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseA Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyOther: High Water IntakeThe Rogosin InstituteWeill Medical College of Cornell UniversityRecruiting18 Years65 YearsAll32N/AUnited States
23NCT02903511November 201614 October 2019Feasibility 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)Not recruiting30 Years60 YearsAll50Phase 2United States
24EUCTR2016-000187-42-GB24/10/201616 January 2017A 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Current Sponsor code: OPC-41061
Other descriptive name: TOLVAPTAN (OPC-41061)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Current Sponsor code: OPC-41061
Other descriptive name: TOLVAPTAN (OPC-41061)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Current Sponsor code: OPC-41061
Other descriptive name: TOLVAPTAN (OPC-41061)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Otsuka Pharmaceutical Development & Commercialization, Inc.AuthorisedFemale: yes
Male: yes
100Phase 3Belgium;Germany;Italy;United Kingdom
25NCT02729662October 1, 201626 August 2019Efficacy of Tolvaptan on ADPKD PatientsLongitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients (LET-PKD Study)Autosomal Dominant Polycystic Kidney DiseaseDrug: TolvaptanKyorin UniversityNot recruiting18 YearsN/AAll118N/AJapan
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26NCT02933268September 26, 201628 January 2019High Water Intake in Polycystic Kidney DiseaseDetermining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility TrialAutosomal Dominant Polycystic Kidney DiseaseDietary Supplement: High water intake;Other: Ad libitum water intakeCambridge University Hospitals NHS Foundation TrustPKD Charity;Addenbrookes Charitable Trust;British Renal Society & British Kidney Patient AssociationNot recruiting16 YearsN/AAll42N/AUnited Kingdom
27NCT02964273September 201613 May 2019Safety, 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: Matching PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Not recruiting4 Years17 YearsAll91Phase 3Belgium;Germany;Italy;United Kingdom
28NCT02656017June 27, 201611 November 2019Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseaseMetformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: Metformin;Other: PlaceboKyongtae Ty Bae, M.D., Ph.D.Tufts Medical Center;University of Maryland, Baltimore;University of Southern California;United States Department of DefenseNot recruiting18 Years60 YearsAll97Phase 2United States
29NCT02697617January 26, 201611 March 2019Use 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 UniversityNot recruiting18 Years55 YearsAll18Phase 2United States
30EUCTR2014-001501-41-BE16/01/20168 August 2016A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specifyTrade Name: Jinarc
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Current Sponsor code: Tolvaptan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Otsuka Pharmaceutical Development & Commercialization, Inc.AuthorisedFemale: yes
Male: yes
20Phase 3France;United States;Argentina;Belgium;Germany;Japan
No.TrialIDDate_
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31NCT02616055December 201511 June 2018Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: tesevatinibKadmon Corporation, LLCNot recruiting18 Years55 YearsAll15Phase 2United States
32NCT03803124December 201521 January 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 HolstebroNot recruiting18 YearsN/AAll20Phase 3Denmark
33NCT02494141November 12, 201527 May 2019Curcumin 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, DenverRecruiting6 Years25 YearsAll68Phase 4United States
34NCT02558595September 22, 201525 February 2019Pilot 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)Not recruiting18 Years60 YearsAll36Phase 2United States
35NCT02776241September 201516 December 2017Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney DiseaseEffect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA StudyADPKDOther: waterRigshospitalet, DenmarkAarhus University HospitalNot recruiting18 YearsN/AAll40N/ADenmark
No.TrialIDDate_
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36EUCTR2015-001903-30-DK26/06/201529 January 2018Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney diseaseEffect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKDAdult 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: Body processes [G] - Physical Phenomena [G01]
Trade Name: Samsca
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Department of Medical ResearchNot RecruitingFemale: yes
Male: yes
30Phase 2Denmark
37EUCTR2014-001516-19-GB26/03/201528 February 2019This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease - Otsuka_156-13-211Autosomal 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: Tolvaptan 15mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Other descriptive name: TOLVAPTAN (OPC-41061)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Product Name: Tolvaptan 30mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Other descriptive name: TOLVAPTAN (OPC-41061)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Otsuka Pharmaceutical Development & Commercialization,Not Recruiting Female: yes
Male: yes
2500Phase 3United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
38JPRN-UMIN0000157152014/11/202 April 2019Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseTolvaptan administrationKyorin University School of MedicineNot Recruiting18years-oldNot applicableMale and Female100Phase 4Japan
39EUCTR2014-001973-15-DK18/11/201411 April 2016The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease. The 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 disease - TOPOHyponatreamia SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) Overhydration Autosomal dominant polycystic kidney disease
MedDRA version: 17.0 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861
MedDRA version: 17.0 Level: LLT Classification code 10040626 Term: SIADH System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNot RecruitingFemale: yes
Male: yes
Denmark
40NCT02134899October 14, 201418 December 2018The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted RecipientsAn Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Everolimus;Drug: Calcineurin inhibitors maintenanceAssistance Publique - Hôpitaux de ParisNovartisNot recruiting18 Years75 YearsAll3Phase 3France
No.TrialIDDate_
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agemin
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agemax
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PhaseCountries
41JPRN-UMIN0000152452014/09/252 April 2019Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.autosomal dominant polycystic kidney disease (ADPKD)tolvaptan 60~120mg/day
tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

no medication
tolvaptan less than 60mg/day of start dose
(in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old)
Department of Medicine four, Tokyo Women's Medical UniversityRecruiting15years-oldNot applicableMale and Female100Not applicableJapan
42NCT02127437September 19, 20148 January 2018Lanreotide In Polycystic Kidney Disease StudyLanreotide In Polycystic Kidney Disease StudyAutosomal Dominant Polycystic Kidney Disease (ADPKDDrug: Lanreotide;Drug: salineAssistance Publique - Hôpitaux de ParisIPSEN pharmaceutical company, Boulogne-Billancourt, FranceNot recruiting18 YearsN/AAll156Phase 3France
43NCT02251275September 201417 June 2019Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan (OPC-41061)Otsuka Pharmaceutical Development & Commercialization, Inc.Not recruiting18 YearsN/AAll1814Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic
44NCT02140814May 201412 December 2016Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseaseUncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: NiacinamideAlan Yu, MB, BChirNot recruiting18 Years50 YearsBoth10Phase 2United States
45NCT02160145May 201416 December 2017Efficacy 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.Not recruiting18 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02225860May 201416 December 2017Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney DiseaseLow Osmolar Diet and Adjusted Water Intake for Vasopressin Suppression in ADPKDAutosomal Dominant Polycystic Kidney Disease (ADPKD)Behavioral: Diet and water adjustmentTufts Medical CenterNot recruiting18 Years60 YearsAll34Phase 2/Phase 3United States
47NCT02115659April 201419 February 2015Triptolide-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 HospitalRecruiting40 Years75 YearsBoth100Phase 3China
48NCT02166489March 201418 January 2016Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney DiseaseEvaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney DiseaseChronic Renal Failure;Polycystic Kidney DiseaseBiological: Intravenous injection autologous mesenchymal stem cellsRoyan InstituteNot recruiting18 Years60 YearsBoth6Phase 1Iran, Islamic Republic of
49NCT02847624March 201430 September 2019Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDPost-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in JapanPolycystic Kidney, Autosomal DominantDrug: tolvaptanOtsuka Pharmaceutical Co., Ltd.RecruitingN/AN/AAll1600N/AJapan
50EUCTR2012-000550-60-AT17/01/201411 June 2018Pulsed oral sirolimus in autosomal dominant polycystic kidney diseasePulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP StudyAutosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy.
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: Rapamune 1mg tablets
Product Name: Rapamune 1mg tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123-88-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3AuthorisedFemale: yes
Male: yes
68Phase 3Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
51NCT02021110December 201318 April 2016Ursodeoxycholic Acid as Treatment for Polycystic Liver DiseaseAn International, Multicenter, Randomized Controlled Clinical Trial Assessing the Efficacy of Ursodeoxycholic Acid as a Volume Reducing Treatment in Symptomatic Polycystic Liver DiseasePolycystic Liver Disease (PLD):;Polycystic Kidney, Autosomal Dominant;Polycystic Liver DiseaseDrug: Ursodeoxycholic AcidRadboud UniversityAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Biodonostia Health Research InstituteNot recruiting18 Years80 YearsBoth34Phase 2Netherlands;Spain
52NCT01932450August 201319 February 2015Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression ControlA Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease;HypertensionProcedure: renal sympathetic denervation;Drug: antihypertensive drugsMei changlinRecruiting20 Years60 YearsBoth100Phase 2China
53NCT01853553July 201326 August 2019Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic KidneyADPKDDrug: Spironolactone;Drug: Sugar pillUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting20 Years55 YearsAll61Phase 3United States
54NCT01559363September 20123 June 2019A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 (Tesevatinib) in Subjects With ADPKDA Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: KD019 (tesevatinib)Kadmon Corporation, LLCNot recruiting22 Years62 YearsAll74Phase 1/Phase 2United States
55NCT01670110August 201213 May 2019Pasireotide 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 ClinicNot recruiting18 Years100 YearsAll48Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01451827October 201119 February 20158-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.Not recruiting18 Years50 YearsBoth178Phase 2United States
57NCT01680250September 201119 February 2015Sirolimus for Massive Polycystic LiverAn Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic LiverPolycystic Kidney DiseasesDrug: SirolimusSeoul National University HospitalWyeth is now a wholly owned subsidiary of PfizerRecruiting18 Years65 YearsBoth44Phase 2/Phase 3Korea, Republic of
58NCT01354405May 201119 February 2015Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney DiseasePolycystic Liver DiseaseDrug: LanreotideRadboud UniversityIpsenNot recruiting18 Years70 YearsBoth43N/ANetherlands
59NCT01377246May 201122 January 2018Somatostatin 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 ResearchNot recruiting18 Years75 YearsAll100Phase 3Italy
60ChiCTR-TRC-110012822011-04-0118 April 2017Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with ProteinuriaTriptolide Retards Autosomal Dominant Polycystic Kidney Disease with ProteinuriaAutosomal dominant polycystic kidney disease;Q61.301Group A:Glucosidorum Tripterygll Totorum+losartan potassium ;Group B:Placebo + losartan potassium;Shanghai Changzheng HospitalNot Recruiting1855BothGroup A:30;Group B:30;Post-marketChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
61EUCTR2009-017849-57-NL24/03/201119 March 2012Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVESomatostatin analogues as a volume reducing treatment of polycystic livers - SOLVEPolycystic liver disease, due to isolated polycystic liver disease or polycystic kidney disease.
MedDRA version: 12.1 Level: LLT Classification code 10048834 Term: Polycystic liver disease
MedDRA version: 12.1 Level: PT Classification code 10048834 Term: Polycystic liver disease
MedDRA version: 12.1 Level: LLT Classification code 10036045 Term: Polycystic kidney
MedDRA version: 12.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant
MedDRA version: 12.1 Level: LLT Classification code 10036048 Term: Polycystic kidney, unspecified type
Product Name: Sandostatin LAR
Product Code: unknown
Pharmaceutical Form: Solution for injection
Product Name: Somatuline Autosolution
Product Code: unknown
Pharmaceutical Form: Solution for injection
Radboud University Nijmegen Medical CentreAuthorisedFemale: yes
Male: yes
Netherlands
62NCT01233869December 201019 October 2017Bosutinib 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: PlaceboPfizerNot recruiting18 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
63JPRN-JapicCTI-10136201/11/201023 April 2019A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251]A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251]Autosomal dominant polycystic kidney disease (ADPKD)Intervention name : Tolvaptan
Dosage And administration of the intervention : Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Otsuka Pharmaceutical Co., Ltd.2353BOTH150Phase 3
64NCT01280721November 201026 October 2015A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: tolvaptanOtsuka Pharmaceutical Co., Ltd.Not recruiting23 Years53 YearsBoth135Phase 3Japan
65NCT01210560October 201019 February 2015Dose-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.Not recruiting18 Years50 YearsBoth25Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
66EUCTR2010-019025-33-NL31/08/201019 March 2012A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctionA Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Otsuka Pharmaceutical Development Commercialization, Inc.Not RecruitingFemale: yes
Male: yes
36Phase 2aNetherlands
67EUCTR2010-018401-10-DE07/07/201011 April 2016A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1 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]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Otsuka Pharmaceutical Development & Commercialization, IncNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
68NCT01214421May 201011 June 2018Open-Label Tolvaptan Study in Subjects With ADPKDMulti-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Not recruiting18 YearsN/AAll1083Phase 3United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Romania;Russian Federation;United Kingdom
69EUCTR2009-012376-27-IT16/11/200927 January 2014EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN IIEFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN IIPolycystic Kidney
MedDRA version: 12.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant
Trade Name: SANDOSTATINA LAR
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Octreotide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use
IST. DI RICERCHE FARMACOLOG. M. NEGRINot RecruitingFemale: yes
Male: yes
Italy
70NCT01022424November 200926 October 2015A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]Autosomal Dominant Polycystic Kidney DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.Not recruitingN/AN/ABoth13Phase 3Japan
No.TrialIDDate_
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Inclusion_
agemax
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PhaseCountries
71NCT01632605November 200919 February 2015The Vienna RAP Pilot StudyRapamycin in Advanced Polycystic Kidney Disease Pilot StudyADPKDDrug: SirolimusMedical University of ViennaNot recruiting18 YearsN/ABoth8N/AAustria
72NCT00890279July 200919 February 2015Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCBKidney, Polycystic, Autosomal DominantDrug: Cilnidipine;Drug: ImidaprilMinistry of Health, Labour and Welfare, JapanRecruiting20 Years60 YearsBoth160Phase 2Japan
73NCT00920309June 200919 October 2017Rapamycin 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 UniversityNot recruiting18 Years70 YearsAll21Phase 2/Phase 3United States
74NCT02119013January 200919 February 2015Effects 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 UniversityNot recruiting18 Years80 YearsBoth35Phase 2/Phase 3
75NCT02119052January 200919 February 2015Effects 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 UniversityNot recruiting18 YearsN/ABoth35Phase 2/Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
76NCT00784030November 200819 October 2017High Water Intake to Slow Progression of Polycystic Kidney DiseaseThe Effect of Water Loading on Urinary BiomarkersKidney, Polycystic, Autosomal DominantOther: WaterNew York University School of MedicineNot recruiting18 Years65 YearsAll23N/AUnited States
77NCT00801268November 20087 April 2015Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney DiseaseRandomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic KidneyDrug: tripterygium wilfordii;Drug: EmodinZhi-Hong Liu, M.D.Not recruiting15 Years70 YearsBoth300N/AChina
78NCT00759369September 200819 February 2015Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Water as Therapy in Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseOther: Water prescriptionUniversity of KansasNot recruiting18 Years50 YearsBoth11N/AUnited States
79NCT01009957June 20083 August 2015Everolimus on CKD Progression in ADPKD PatientsEverolimus on CKD (Chronic Kidney Disease) Progression in ADPKD PatientsPolycystic Kidney DiseasesDrug: EverolimusA. Manzoni HospitalNot recruiting18 YearsN/ABoth71Phase 2/Phase 3Italy
80NCT00771888April 200819 February 2015Open-Label Extension of LOCKCYST TrialOpen-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic LiversPolycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney;Autosomal DominantDrug: lanreotideRadboud UniversityIpsenNot recruiting18 Years88 YearsBoth54Phase 2/Phase 3Belgium;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
81EUCTR2007-005047-21-IT24/12/200724 July 2012Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA IIAutosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 9.1 Level: LLT Classification code 10010428 Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*100CPR RIV 1MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: RAPAMUNE*30CPR RIV 2MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
IST. DI RICERCHE FARMACOLOG. M. NEGRINot RecruitingFemale: yes
Male: yes
Italy
82EUCTR2007-006557-25-IT20/12/200710 July 2012RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDYRAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDYADPKD type I
MedDRA version: 9.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders
Trade Name: RAPAMUNE*100CPR RIV 1MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: Ramipril
Pharmaceutical Form: Tablet
INN or Proposed INN: Ramipril
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALENot RecruitingFemale: yes
Male: yes
Italy
83NCT00565097October 200719 February 2015Lanreotide 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 UniversityIpsenNot recruiting18 Years88 YearsBoth38Phase 2/Phase 3Belgium;Netherlands
84JPRN-JapicCTI-07040201/7/20072 April 2019Tolvaptan 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)
Dosage And administration of the intervention : Oral, 45/15 mg
Intervention name : OPC-41061 (tolvaptan)
Dosage And administration of the intervention : Oral, 60/30 mg
Intervention name : OPC-41061 (tolvaptan)
Dosage And administration of the intervention : Oral, 90/30 mg
Control intervention name : Placebo
Dosage And administration of the control intervention : Oral
Otsuka Pharmaceutical Co., Ltd.2050BOTH1500Phase 3
85EUCTR2006-003427-37-IT05/02/200719 March 2012Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - NDSirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - NDAutosomal-Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 9.1 Level: LLT Classification code 10010428 Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*30CPR RIV 1MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: RAPAMUNE*30CPR RIV 2MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
IST. DI RICERCHE FARMACOLOG. M. NEGRINot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2006-002768-24-DK26/01/200720 May 2013A 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)
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061, OPC-156
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Current Sponsor code: OPC-41061, OPC-156
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Otsuka Pharmaceutical Development & Commercialization, Inc.Not RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;Italy;United Kingdom
87NCT00426153January 200719 October 2017Octreotide 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)Not recruiting18 Years80 YearsAll42Phase 2/Phase 3United States
88EUCTR2006-001485-16-AT15/12/200627 January 2014A 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) - ADPKDpolycystic kidney disease
MedDRA version: 8.1 Level: LLT Classification code 10011771 Term: Cystic kidney disease
Product Name: Certican Tabletten
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
89NCT00456365November 200619 February 2015Effect 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)Not recruiting8 Years21 YearsBoth112Phase 3United States
90NCT00286156October 200619 October 2017Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseasesDrug: RapamuneThe Cleveland ClinicWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years75 YearsAll30Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00598377September 200619 February 2015Adrenal Functions in Autosomal Dominant Polycystic Kidney DiseaseAssessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: TetracosactinIstanbul UniversityNot recruiting20 Years56 YearsBoth49N/ATurkey
92NCT00346918June 200619 February 2015Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study.Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Sirolimus;Other: StandardUniversity of ZurichNot recruiting18 Years40 YearsBoth100Phase 3Switzerland
93NCT00345137May 200619 February 2015Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic GlomerulonephritisPhase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic GlomerulonephritisADPKD;GlomerulonephritisDrug: Ng-monomethyl-L-arginine (drug)Regional Hospital HolstebroNot recruiting20 Years60 YearsBoth75Phase 1
94NCT00309283April 200619 February 2015Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up StudyEffect of a Long-acting Somatostatin on Disease Progression in Nephropathy Due to Autosomal Dominant Polycystic Kidney Disease: a Long-term Three Year Follow up StudyAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Long-acting somatostatin;Other: Saline solutionMario Negri Institute for Pharmacological ResearchNot recruiting18 Years75 YearsBoth78Phase 3Italy
95NCT00841568April 200619 February 2015A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]Autosomal Dominant Polycystic Kidney DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.Not recruitingN/AN/ABoth17Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT00283686January 200619 October 2017HALT Progression of Polycystic Kidney Disease (HALT PKD) Study APolycystic Kidney Disease-Treatment NetworkKidney, 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 FoundationNot recruiting15 Years64 YearsAll558Phase 3United States
97NCT01885559January 200619 October 2017HALT Progression of Polycystic Kidney Disease (HALT PKD) Study BPolycystic Kidney Disease-Treatment NetworkKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease FoundationNot recruiting15 Years64 YearsAll486Phase 3United States
98NCT00413777December 200516 December 2017Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Not recruiting18 YearsN/AAll46Phase 2United States
99EUCTR2005-003182-16-GB26/08/200524 April 2012Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs.Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs.Polycystic kidney diseaseTrade Name: CARDURA
Product Name: DOXAZOSIN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: MONOCOR
Product Name: BISOPROLOL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: ZESTRIL
Product Name: LISINOPRIL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: ISTIN
Product Name: AMLODIPINE
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: AMIAS
Product Name: CANDESARTAN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: APRINOX
Product Name: BENDROFLUMETHIAZIDE
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Addenbrooke's Hospital TrustAuthorisedFemale: yes
Male: yes
42United Kingdom

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