Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

Key facts

Study ID

NCT00323297

Run by

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

People needed

105

Starts

2006-09-01

Expected to finish

2013-08-01

Last updated by the study team

2021-02-01

Who can join

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

You may qualify if…

• Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
• Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge pressure of <15mmHg at rest via right heart catheterization within 3 years prior to randomization.
• Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.

You may not qualify if…

• PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
• Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.

Where it is running

• West Los Angeles VA Healthcare, Pulmonary Hypertension Program — Los Angeles, California, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• St. Vincents Hospital — Darlinghurst, New South Wales, Australia
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• Institut klinicke a experimentalni mediciny, Klinika kardiologie — Prague, Czechia
• Clinique des Maladies Respiratoires — Lille, France
• Hopital Claude Huriez — Lille, France
• Hopital Adules Brabois — Vandœuvre-lès-Nancy, France
• Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin — Berlin, Germany
• II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie — Coburg, Germany
• Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie — Essen, Germany
• Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen — Giessen, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Universitaetsklinikum des Saarlandes, Innere Medizin V — Homburg, Germany
• Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig — Leipzig, Germany
• Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern — München, Germany
• Praxis fuer Innere Medizin, Kardiologie und Angiologie — Nuremberg, Germany
• Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH — Würzburg, Germany
• Attikon Hospital — Haidari, Athens, Greece
• Rambam Medical Center — Haifa, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.