NCT00384865

A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH).

Detailed description

PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. In PAH, in situ thrombosis may occur in the lungs, and pulmonary endothelial dysfunction is well-recognized. As aspirin inhibits platelet aggregation, there may be value in using aspirin to treat PAH. Simvastatin has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, simvastatin may similarly benefit patients with PAH. Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets, daily aspirin and daily placebo, daily simvastatin and daily placebo, or daily aspirin and daily simvastatin in a double-blind fashion. The study will compare the safety and efficacy of aspirin to placebo and simvastatin to placebo.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin 40 mg, taken orally, once a day for 6 months
DRUG	Aspirin	Aspirin 81 mg, taken orally, once a day for 6 months
DRUG	Placebo	Placebo, taken orally, once a day for 6 months

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-10-06
• Last updated: 2017-07-21
• Results posted: 2017-07-21

Locations

4 sites across 1 country: United States