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Combination Therapy in Pulmonary Arterial Hypertension

Study:

COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling

Rationale:

n/a

Purpose:

An open label, non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute walk distance (6 MWD) of =380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Bosentan
Drug: Sildenafil
Phase 4

Verified by Actelion May, 2013

Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov identifier: NCT00433329

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

n/a

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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