CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Simvastatin 40 mg once daily for 1 month, then 80 mg once daily for 11 monthsAI-extracted
Key inclusion· 5
  • ✓Idiopathic PAH or PAH related to collagen vascular disease
  • ✓Age 18 years or older
  • ✓Stable on conventional therapy (diuretics, digoxin, warfarin, sildenafil, bosentan) for at least 1 month
  • ✓6-minute walk distance between 150 and 450 meters
Key exclusion· 6
  • ✕PAH from a cause other than idiopathic or collagen vascular disease-related
  • ✕Change in PAH treatment within past 4 weeks
  • ✕Currently requiring prostanoid therapy
  • ✕Already taking a statin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00180713
NCT00180713Phase 2Completed
CompareCT.gov

Simvastatin as a Treatment for Pulmonary Hypertension

Imperial College London·interventional·Posted Sep 16, 2005·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating Simvastatin and Placebo for Pulmonary Hypertension. Completed, enrolled 42 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesGermany, United Kingdom
CollaboratorsMedical Research Council

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

Simvastatindrug

Simvastatin 40mg od for 1 month, then 80mg od for 11 months

Placebodrug

Placebo tablet once daily.