Tvp-1012 (DrugBank: -)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
6 | パーキンソン病 | 12 |
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 |
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1 | NCT02337751 (ClinicalTrials.gov) | July 10, 2015 | 9/1/2015 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 198 | Phase 3 | Japan |
2 | NCT02337725 (ClinicalTrials.gov) | February 7, 2015 | 9/1/2015 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 80 Years | All | 244 | Phase 3 | Japan |
3 | NCT02337764 (ClinicalTrials.gov) | February 3, 2015 | 9/1/2015 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 222 | Phase 3 | Japan |
4 | NCT02337738 (ClinicalTrials.gov) | January 27, 2015 | 9/1/2015 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off | Parkinson's Disease | Drug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 79 Years | All | 404 | Phase 2;Phase 3 | Japan |
5 | JPRN-JapicCTI-152762 | 27/1/2015 | A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's disease | Intervention name : TVP-1012 (1 mg/day) with levodopa Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period. Control intervention name : null | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 30 | 79 | BOTH | 215 | Phase 3 | NULL | ||
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 |
6 | EUCTR2006-005140-89-NL (EUCTR) | 11/12/2006 | 01/12/2006 | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536 | Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate | TEVA Pharmaceuticals Industries Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 1 | Netherlands | ||
7 | EUCTR2005-001416-42-PT (EUCTR) | 07/11/2005 | 25/08/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Portugal;Germany;United Kingdom;Spain;Italy | |||
8 | EUCTR2005-001416-42-HU (EUCTR) | 27/09/2005 | 20/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | |||
9 | EUCTR2005-001416-42-DE (EUCTR) | 01/09/2005 | 17/10/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;United Kingdom;Germany;Spain;Italy | |||
10 | EUCTR2005-001416-42-AT (EUCTR) | 24/08/2005 | 20/07/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | |||
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 |
11 | EUCTR2005-001416-42-IT (EUCTR) | 14/07/2005 | 21/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | Neuroprotective early treatment of Parkinson's disease subjects MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: NA Other descriptive name: NA Product Name: rasagiline Product Code: TVP-1012 | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | ||||
12 | NCT00203125 (ClinicalTrials.gov) | October 2000 | 13/9/2005 | A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study. | Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133) | Parkinson's Disease | Drug: rasagiline mesylate;Other: tyramine | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | Both | 55 | Phase 3 | United States |