Viewing Study NCT00384865



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00384865
Status: TERMINATED
Last Update Posted: 2017-07-21
First Post: 2006-09-30

Brief Title: A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension
Sponsor: University of Pennsylvania
Organization: University of Pennsylvania

Study Overview

Official Title: A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension
Status: TERMINATED
Status Verified Date: 2017-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL082895-01 NIH None httpsreporternihgovquickSearchR01HL082895-01