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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00433329 |
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 PAH to achieve a 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.
Condition | Intervention | Phase |
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Pulmonary Arterial Hypertension |
Drug: bosentan Drug: bosentan and sildenafil combination |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-MWT Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of MRI on Cardiac Remodeling |
Estimated Enrollment: | 100 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Bosentan monotherapy
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Drug: bosentan
Oral bosentan 62.5 mg BID for 4 weeks followed by 24 weeks of 125 mg BID
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B: Active Comparator
bosentan and sildenafil combination therapy
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Drug: bosentan and sildenafil combination
Oral bosentan 62.5 mg BID for 4 weeks followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptomatic patients with the following types of PAH belonging to WHO Pulmonary Hypertension Classification
Group I:
Associated with PAH (APAH):
Patients naïve to treatment with advanced PAH therapies (i.e., ERAs, PDE-5 inhibitors or prostacyclins) with a RHC showing all of the following:
Exclusion Criteria:
Responsible Party: | Actelion ( Lee Golden, MD ) |
Study ID Numbers: | AC-052-419 |
Study First Received: | February 7, 2007 |
Last Updated: | August 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00433329 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pulmonary arterial hypertension bosentan sildenafil combination therapy Compass 3 |
Vasodilator Agents Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Hypertension |
Vascular Diseases Sildenafil Cardiovascular Agents Antihypertensive Agents Bosentan Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Sildenafil Cardiovascular Agents Antihypertensive Agents Bosentan |
Pharmacologic Actions Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Hypertension |