IRBESARTAN ( DrugBank: Irbesartan )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
66IgA腎症14
167マルファン症候群3
168エーラス・ダンロス症候群2
222一次性ネフローゼ症候群18

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004605-41-DE
(EUCTR)
20/07/201925/06/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Overencapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (ANDA 203071)
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (NDA 020 757)
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
2EUCTR2017-004605-41-PT
(EUCTR)
04/02/201924/08/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
3EUCTR2017-004605-41-PL
(EUCTR)
17/01/201905/11/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/over-encapsulated Spasenten tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
4NCT03762850
(ClinicalTrials.gov)
December 11, 201827/11/2018A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA NephropathyA Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A NephropathyImmunoglobulin A NephropathyDrug: sparsentan;Drug: irbesartan;Drug: DapagliflozinTravere Therapeutics, Inc.NULLActive, not recruiting18 YearsN/AAll380Phase 3United States;Australia;Belgium;Croatia;Czechia;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;Lithuania;New Zealand;Poland;Portugal;Spain;Taiwan;United Kingdom
5EUCTR2017-004605-41-HR
(EUCTR)
23/11/201816/05/2019Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
6EUCTR2017-004605-41-IT
(EUCTR)
25/10/201828/01/2021Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan compresse
Product Code: [RE-021]
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
Product Code: C09
Trade Name: SMOFKABIVEN - EMULSIONE PER INFUSIONE SENZA ELETTROLITI 1 SACCA BIOFINE MULTICOMPARTIMENTATE DA 493 ML
Product Name: over-encapsulated Irbesartan Tablets
Product Code: [000000000]
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
RETROPHIN, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
7EUCTR2017-004605-41-GB
(EUCTR)
04/10/201804/06/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - 021IGAN17001 (PROTECT) Sparsentan in IGAN Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Overencapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: Irbesartan
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
8EUCTR2017-004605-41-CZ
(EUCTR)
03/10/201817/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
9EUCTR2017-004605-41-BE
(EUCTR)
28/09/201806/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/ Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
10EUCTR2017-004605-41-ES
(EUCTR)
27/09/201830/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 150 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Estonia;Hong Kong;Spain;Lithuania;Turkey;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Malaysia;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
11EUCTR2017-004605-41-EE
(EUCTR)
05/09/201831/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
12EUCTR2017-004605-41-LT
(EUCTR)
23/08/201802/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
13NCT00657059
(ClinicalTrials.gov)
September 20078/4/2008Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)IgA NephropathyDrug: irbesartan;Drug: methylprednisolone (MP) or prednisone (pred);Drug: mycophenolate mofetil (MMF)Sun Yat-sen UniversityNULLCompleted14 Years60 YearsAll151Phase 3China
14EUCTR2005-003885-40-IT
(EUCTR)
18/10/200515/01/2007ACE-inhibitors and Angiotensin two receptor antagonists in IgA nephropathy with mild proteinuria - The primary aim of the study consists in testing the hypothesis that blockade of the RAS may decrease the risk of developing adverse effects in patients with benign IgAN.Such blockade would first achieved with unique pharmacological class then shifting to the association of the two classes as soon as ineffective blockade is documented
MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders
Product Name: Ramipril
INN or Proposed INN: Ramipril
Product Name: Irbesartan
INN or Proposed INN: Irbesartan
AZIENDA OSPEDALIERA PROVINCIALE DI LECCONULLNot RecruitingFemale: yes
Male: yes
Italy

167. マルファン症候群


臨床試験数 : 21 薬物数 : 40 - (DrugBank : 11) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 50
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01949233
(ClinicalTrials.gov)
October 20136/8/2013The Oxford Marfan TrialA Randomised, Double-blind, Placebo-controlled Pilot Trial of Irbesartan, Doxycycline and a Combination on Markers of Vascular Dysfunction in the Marfan Syndrome, Using Cardiovascular Magnetic Resonance ImagingMarfan SyndromeDrug: Irbesartan 150-300mg capsules daily for 6 months;Drug: Doxycycline 100-200mg capsules daily for 6 months;Drug: Doxycycline placebo capsules daily for 6 months;Drug: Irbesartan placebo capsules daily for 6 monthsUniversity of OxfordOxford University Hospitals NHS TrustRecruiting13 YearsN/ABoth56Phase 2United Kingdom
2EUCTR2010-023612-14-GB
(EUCTR)
08/03/201320/12/2012The Oxford Marfan Trial A randomised, double-blind, placebo-controlled pilot trial of irbesartan, doxycycline and a combination on markers of vascular dysfunction in the Marfan syndrome, using cardiovascular magnetic resonance imaging - The Oxford Marfan Trial Version 1.0 Marfan syndrome.
MedDRA version: 14.1;Level: PT;Classification code 10026829;Term: Marfan's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Aprovel
Product Name: Aprovel
INN or Proposed INN: Irbesartan
Trade Name: Vibrox 100mg Capsules
Product Name: Vibrox
INN or Proposed INN: Doxycycline Hyclate Ph.Eur
Clinical Trials and Research GovernanceNULLNot Recruiting Female: yes
Male: yes
56 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
3EUCTR2010-019302-16-GB
(EUCTR)
13/09/201017/08/2010A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndromeA prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome - The AIMS Study Marfan SyndromeTrade Name: Aprovel
Product Name: Aprovel
INN or Proposed INN: Irbesartan
INN or Proposed INN: Irbesartan
INN or Proposed INN: Irbesartan
Royal Brompton and Harefield NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom

168. エーラス・ダンロス症候群


臨床試験数 : 13 薬物数 : 21 - (DrugBank : 11) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02597361
(ClinicalTrials.gov)
January 201623/10/2015Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.Ehlers-Danlos Syndrome, Vascular TypeDrug: Irbesartan;Drug: PlaceboAssistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted18 Years70 YearsAll61Phase 3France
2EUCTR2015-001065-76-FR
(EUCTR)
28/09/201508/09/2015N/AN/A - ARCADE
MedDRA version: 18.0;Level: PT;Classification code 10014316;Term: Ehlers-Danlos syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: IRBESARTAN
Product Name: IRBESARTAN
INN or Proposed INN: irbesartan
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
169Phase 3France

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-005141-23-PT
(EUCTR)
23/09/201912/04/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
2EUCTR2016-005141-23-SE
(EUCTR)
31/07/201928/03/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Korea, Republic of;Sweden
3EUCTR2016-005141-23-HR
(EUCTR)
25/07/201911/10/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Argentina;Hong Kong;Hungary;United States;United Kingdom;Portugal;Spain;New Zealand;Canada;Czech Republic;Sweden;Belgium;Taiwan;Brazil;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany;Croatia;Estonia
4EUCTR2016-005141-23-BE
(EUCTR)
15/07/201914/05/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
5EUCTR2016-005141-23-DE
(EUCTR)
28/05/201930/05/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablet
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (NDC# 43547-0374-03 and NDC 43547-374-09, approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (NDC# 31722-729-30 approved in the United states)
Product Name: Over-encapsulated Irbesartan Tablets
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
6EUCTR2016-005141-23-EE
(EUCTR)
07/05/201927/03/2019A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
7EUCTR2016-005141-23-PL
(EUCTR)
20/11/201825/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Estonia;Argentina;Hong Kong;Hungary;United States;United Kingdom;Portugal;Spain;New Zealand;Canada;Czech Republic;Sweden;Belgium;Taiwan;Poland;Brazil;Denmark;Korea, Republic of;Italy;Australia;France;Germany;Croatia
8EUCTR2016-005141-23-DK
(EUCTR)
05/11/201802/08/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
9EUCTR2016-005141-23-ES
(EUCTR)
28/09/201821/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 75 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of
10EUCTR2016-005141-23-GB
(EUCTR)
18/09/201802/05/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) - DUPLEX (021FSGS16010) Sparsentan in FSGS Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
11EUCTR2016-005141-23-IT
(EUCTR)
17/09/201815/01/2021Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) - Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis ( Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: [R-021]
Trade Name: Irbesartan
Product Name: IRBESARTAN
Product Code: [SUB08293MIG]
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan
Product Code: [over-encapsulated Irbesartan]
INN or Proposed INN: Irbesartan
Other descriptive name: Irbesartan
RETROPHIN, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Taiwan;Hong Kong;Estonia;Spain;Italy;Switzerland;France;Australia;Denmark;South Africa;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
12EUCTR2016-005141-23-CZ
(EUCTR)
05/09/201813/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
13EUCTR2016-005141-23-HU
(EUCTR)
29/08/201826/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 75 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Estonia;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Sweden;Korea, Republic of
14NCT03493685
(ClinicalTrials.gov)
April 17, 20183/4/2018Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGSFocal Segmental GlomerulosclerosisDrug: sparsentan;Drug: IrbesartanTravere Therapeutics, Inc.NULLActive, not recruiting8 Years75 YearsAll371Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;New Zealand;Poland;Portugal;Spain;Sweden;Taiwan;United Kingdom;Hungary
15EUCTR2014-002358-38-CZ
(EUCTR)
28/04/201514/10/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Czech Republic;Belgium;Italy
16EUCTR2014-002358-38-BE
(EUCTR)
05/02/201525/11/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 17.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Czech Republic;Belgium;Italy
17EUCTR2014-002358-38-IT
(EUCTR)
15/12/201419/11/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 17.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Czech Republic;Belgium;Italy
18NCT01613118
(ClinicalTrials.gov)
March 20144/6/2012Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental GlomerulosclerosisEfficacy and Safety of RE-021, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation StudyFocal Segmental GlomerulosclerosisDrug: RE-021 (Sparsentan);Drug: IrbesartanTravere Therapeutics, Inc.NULLActive, not recruiting8 Years75 YearsAll109Phase 2United States;Czechia;Italy;Belgium;Czech Republic