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Combination Therapy in Pulmonary Arterial Hypertension (COMPASS 3) Clinical TrialFroedtert & the Medical College of Wisconsin are seeking participants for the COMPASS 3 clinical study, a study being conducted at centers throughout the United States.
COMPASS 3 is a study to evaluate the effectiveness of the drug bosentan, alone or in combination with the drug sildenafil to improve a patient’s ability to exercise.
The study will also explore how the structure of the heart changes when taking bosentan alone or in combination with sildenafil. This is done with cardiac MRI, right heart catheterization and echocardiogram.
This study will evaluate a total of 100 participants nationwide. The primary objective is to determine the percentage of patients who achieve a target 6-minute walk distance of 380 meters (415 yards) or more, using a bosentan-based, stepped approach to therapy.
A stepped approach means the study patients receive:
Oral bosentan 62.5 mg twice a day for 4 weeks, followed by 24 weeks of 125 mg twice a day. Sildenafil 20 mg three times a day will be added for patients who do not reach the 6-minute walk distance threshold at week 16.
Eligible patients must:
- Have pulmonary arterial hypertension (PAH) but not be receiving advanced PAH treatment
- Be at least 18 years of age
For more information on participating in the COMPASS 3 study, please call Dr. Gary Kung at 414-456-7046 at the Medical College of Wisconsin, or visit www.clinicaltrials.gov (study identifier: NCT00433329).
Author: Marla Fraunfelder | Medical Reviewer: | Gary Kung, MD |
Last Review Date: June 10, 2008 |
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