Vamarolone (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 113 | 筋ジストロフィー | 3 |
| 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 | EUCTR2016-004262-26-GB (EUCTR) | 16/02/2017 | 21/12/2020 | A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy(DMD) | VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne MuscularDystrophy (DMD) | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden | ||
| 2 | EUCTR2016-004263-38-SE (EUCTR) | 13/02/2017 | 16/12/2016 | An Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy(DMD) | A Phase II Open-label, Multicenter Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone | ReveraGen BioPharma Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden | ||
| 3 | EUCTR2016-004262-26-SE (EUCTR) | 13/02/2017 | 16/12/2016 | A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | A Phase IIa, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone | ReveraGen BioPharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden |