Simvastatin 40 mg (DrugBank: Simvastatin)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
86 | 肺動脈性肺高血圧症 | 1 |
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 | EUCTR2005-004863-41-DE (EUCTR) | 04/10/2006 | 25/07/2006 | Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension(Shorttitle: SIPHT)Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months - SIPHT | Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension(Shorttitle: SIPHT)Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months - SIPHT | Modified NYHA class II or III patients with Pulmonary Hypertension (PH), ICD: 416.9 MedDRA version: 8.1;Level: LLT;Classification code 10020787;Term: Hypertension pulmonary | Trade Name: simvastatin 40 mg tablets Product Name: simvastatin Product Name: simvastatin 40 mg Product Code: simvastatin 40 mg INN or Proposed INN: simvastatin | Dept. of Internal Medicine II, University Hospital Giessen | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3-b | Germany |