Pramipexole dihydrochloride extended-release tablets (DrugBank: Pramipexole)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 0 |
| 6 | パーキンソン病 | 2 |
| 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 | EUCTR2017-001420-21-DE (EUCTR) | 18/06/2018 | 16/02/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. | Early Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: P2B001 INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Product Name: Pramipexole dihydrochloride INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Product Name: Rasagiline INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Pramipexole dihydrochloride extended-release tablets Product Name: Pramipexole dihydrochloride extended-release tablets INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE | Pharma Two B Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | United States;France;Canada;Spain;Germany | ||
| 2 | EUCTR2017-001420-21-ES (EUCTR) | 13/06/2018 | 15/03/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. | Early Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: P2B001 INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Product Name: Pramipexole dihydrochloride INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Product Name: Rasagiline INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Pramipexole dihydrochloride extended-release tablets Product Name: Pramipexole dihydrochloride extended-release tablets INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE | Pharma Two B Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | United States;France;Canada;Spain;Germany |