To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

Stopped early · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Key facts

Study ID

NCT00430716

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

130

Starts

2008-04-08

Expected to finish

2010-05-25

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is >/= 100 m and </= 450 m.
• Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery wedge pressure of </= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

You may not qualify if…

• Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
• Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).

Where it is running

• Arizona Pulmonary Specialists, LTD — Phoenix, Arizona, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Atlanta Institute for Medical Research, Inc. — Decatur, Georgia, United States
• Chicago Heart Institute — Elk Grove Village, Illinois, United States
• The Care Group, LLC — Indianapolis, Indiana, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Mid Carolina Cardiology — Charlotte, North Carolina, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• Baylor College of Medicine Pulmonary Section — Houston, Texas, United States
• St. Luke's Episcopal Hospital — Houston, Texas, United States
• University of Utah Sciences Center — Salt Lake City, Utah, United States
• CJW Chippenham Medical Center — Richmond, Virginia, United States
• Pulmonary Associates of Richmond, Inc. — Richmond, Virginia, United States
• Virginia Cardiovascular Specialists — Richmond, Virginia, United States
• Cardiovascular Associates of Virginia — Richmond, Virginia, United States
• Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven, Belgium
• Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
• Instituto Dante Pazzanese de Cardiologia — São Paulo, São Paulo, Brazil
• Peta mnogoprofilna bolnitsa za aktivno lechenie, Klinika po kardiologia — Sofia, Bulgaria
• Mnogoprofilna bolnitsa za aktivno lechenie i speshna meditsina "N.I.Pirogov" — Sofia, Bulgaria
• Beijing Shijitan Hospital — Beijing, China
• Shanghai Pulmonology Hospital — Shanghai, China
• Attikon Hospital — Haidari, Athens, Greece
• Care Hospital, The Institute of Medical Sciences — Hyderabad, Andhra Pradesh, India
• Mehta Hospital & Cardiopulmonary Care Center — Ahmedabad, Gujarat, India

Full record on ClinicalTrials.gov

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