Simvastatin 40 mg tablets ( 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

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
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PhaseCountries
1EUCTR2005-004863-41-DE
(EUCTR)
04/10/200625/07/2006Clinical 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 - SIPHTClinical 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 GiessenNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Germany