Sparsentan tablets/overencapsulated sparsentan tablets (DrugBank: Sparsentan)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 66 | IgA nephropathy | 2 |
| 222 | Primary nephrotic syndrome | 0 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004605-41-DE (EUCTR) | 20/07/2019 | 25/06/2018 | Effectiveness 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 (NDC# 43547-375-50 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 Other descriptive name: IRBESARTAN Trade Name: Irbesartan approved in the Netherlands Product Name: over-encapsulated Irbesartan tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets (NDC# 0955-1041-90 approved in the USA) 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 | Retrophin, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United States;Portugal;Czechia;Estonia;Taiwan;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 2 | EUCTR2017-004605-41-GB (EUCTR) | 04/10/2018 | 04/06/2018 | Effectiveness 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of |