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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00384865 |
The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH).
Condition | Intervention | Phase |
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Hypertension, Pulmonary |
Drug: Simvastatin Drug: Aspirin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension |
Estimated Enrollment: | 128 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Aspirin 81 mg + Simvastatin 40 mg
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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
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2: Active Comparator
Aspirin 81 mg + Placebo
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Drug: Aspirin
Aspirin 81 mg, taken orally, once a day for 6 months
Drug: Placebo
Placebo, taken orally, once a day for 6 months
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3: Active Comparator
Placebo + Simvastatin 40 mg
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Drug: Simvastatin
Simvastatin 40 mg, taken orally, once a day for 6 months
Drug: Placebo
Placebo, taken orally, once a day for 6 months
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4: Placebo Comparator
Placebo + Placebo
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Drug: Placebo
Placebo, taken orally, once a day for 6 months
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Jude Aidam 410-614-1316 jaidam1@jhu.edu | |
Principal Investigator: Reda E. Girgis, MB, BCh | |
Sub-Investigator: Paul Hassoun, MD | |
Sub-Investigator: Wendy Post, MD, MS | |
Sub-Investigator: Ari Zaiman, MD, PhD | |
United States, Massachusetts | |
Tufts University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02110 | |
Contact: Karen Visnaw, RN 617-636-1334 KVisnaw@tufts-nemc.org | |
Contact: Tahiyyah Tai Muhammad 617-636-3269 tmuhammad@tuftsmedicalcenter.org | |
Principal Investigator: Kari Roberts, MD | |
Sub-Investigator: Nicholas Hill, MD | |
Sub-Investigator: Ioana Preston, MD | |
Sub-Investigator: Karen Visnaw, RN | |
Sub-Investigator: Elaine Purcell, MD | |
Sub-Investigator: Samaan Rafeq, MD | |
Sub-Investigator: Archan Shah, MD | |
Sub-Investigator: Farhan Siddiqui, MD | |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Debbie Rybak 212-305-5836 dr2359@columbia.edu | |
Contact: Nisha Philip, MBBS 212-305-7720 np2173@columbia.edu | |
Principal Investigator: David J. Lederer, MD, MS | |
Sub-Investigator: Emilia Bagiella, PhD | |
Sub-Investigator: R. Graham Barr, MD | |
Sub-Investigator: Shunichi Homma, MD | |
Sub-Investigator: Evelyn Horn, MD | |
Sub-Investigator: Sudhir Marathe, PhD | |
Sub-Investigator: Daichi Shimbo, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Diane Pinder 215-662-9716 pinder@mail.med.upenn.edu | |
Contact: Darren Taichman, MD darren.taichman@uphs.upenn.edu | |
Principal Investigator: Steven M Kawut, MD, MS | |
Sub-Investigator: Darren Taichman, MD |
Principal Investigator: | Steven M Kawut, MD, MS | University of Pennsylvania |
Principal Investigator: | David J Lederer, MD, MS | Columbia University |
Principal Investigator: | Reda E Girgis, MB, BCh | Johns Hopkins University |
Principal Investigator: | Kari E Roberts, MD | Tufts University |
Responsible Party: | University of Pennsylvania ( Steven Kawut, MD, MS ) |
Study ID Numbers: | 458, R01 HL082895-01 |
Study First Received: | September 30, 2006 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00384865 History of Changes |
Health Authority: | United States: Federal Government |
Pulmonary Arterial Hypertension |
Antimetabolites Anti-Inflammatory Agents Simvastatin Antilipemic Agents Cyclooxygenase Inhibitors Vascular Diseases Fibrinolytic Agents Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Fibrin Modulating Agents Respiratory Tract Diseases |
Aspirin Hypertension, Pulmonary Analgesics, Non-Narcotic Lung Diseases Idiopathic Pulmonary Hypertension Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Hypertension |
Antimetabolites Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Aspirin Respiratory Tract Diseases Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Simvastatin |
Antilipemic Agents Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic Hypertension, Pulmonary Lung Diseases Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |