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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 |
---|---|
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:
United States, Alabama | |
University of Alabama Hospital at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Pamela Rhodes, RN 205-934-8767 prhodes@cardmail.dom.uab.edu | |
Principal Investigator: Barry Rayburn, MD | |
University of South Alabama | Recruiting |
Mobile, Alabama, United States, 36617 | |
Contact: Majid Mughal, MD 251-471-7029 mmughal@usouthal.edu | |
Principal Investigator: Majid Mughal, MD | |
United States, California | |
Cedars Sinai Medical Center | Withdrawn |
Los Angeles, California, United States, 90048 | |
UCLA - David Geffen School of Medicine | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: David Ross, MD 310-206-8328 dross@mednet.ucla.edu | |
Principal Investigator: David Ross, MD | |
United States, Delaware | |
Lung Health and Sleep Enhancement Center, LLC | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Julie Adams 302-368-5515 ext Option 9 jadams@pulmonarydoctors.com | |
Principal Investigator: Gerald M. O'Brien, MD | |
United States, Florida | |
Morton Plant Hospital (Bay Area Chest Physicians, P.A.) | Recruiting |
Clearwater, Florida, United States, 33756 | |
Contact: Devendra Amin, MD 727-443-0611 alveoli.dna@verizon.net | |
Principal Investigator: Devendra Amin, MD | |
University of Miami School of Medicine | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Debra Fertel, MD 305-585-6487 dfertel@med.miami.edu | |
Principal Investigator: Debra Fertel, MD | |
Sarasota Memorial Hospital-Clinical Research Center | Withdrawn |
Sarasota, Florida, United States, 34239 | |
Cleveland Clinic Florida | Recruiting |
Weston, Florida, United States, 33331 | |
Contact: Franck Rahagi, MD 954-659-5450 rahaghf@ccf.org | |
Principal Investigator: Franck Rahagi, MD | |
Mayo Clinic Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32258 | |
Contact: Pam Long 904-953-7719 long.pamela@mayo.edu | |
Principal Investigator: Jesus Diaz, MD | |
United States, Georgia | |
Emory University Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Micah Fisher, MD 404-727-9651 Micah.Fisher@emoryhealthcare.org | |
Principal Investigator: Micah Fisher, MD | |
Atlanta Institute for Medical Research, Inc. | Recruiting |
Decatur, Georgia, United States, 30030 | |
Contact: Jeffrey E Michaelson, MD 404-966-3775 michaelson@bellsouth.net | |
Principal Investigator: Jeffrey E Michaelson, MD | |
United States, Kentucky | |
Kentukiana Pulmonary Associates | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: John McConnell, MD 502-587-8000 | |
Principal Investigator: John McConnell, MD | |
United States, Maryland | |
University of Maryland School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Myung Park, MD 410-328-7260 mpark@medicine.umaryland.edu | |
Principal Investigator: Myung Park, MD | |
United States, Massachusetts | |
Boston Children's Hospital-BACH Cardiology | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Elizabeth Rodriguez 617-355-0646 elizabeth.rodriguez-huertas@cardio.CHBOSTON.org | |
Principal Investigator: Michael Singh, MD | |
United States, Minnesota | |
Mayo Clinic - Pulmonary Hypertension Clinic | Withdrawn |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Murali Chakinala, MD 314-454-8766 mchakina@im.wustl.edu | |
Principal Investigator: Murali Chakinala, MD | |
United States, New York | |
Columbia University Medical Center | Withdrawn |
New York, New York, United States, 10032 | |
Buffalo General Hospital / Kaleida Health | Recruiting |
Buffalo, New York, United States, 14203 | |
Contact: William J. Gibbons, MD 716-859-2271 wgibbons@kaleidahealth.org | |
Principal Investigator: William J. Gibbons, MD | |
United States, Ohio | |
Ohio State University Medical Center-Davis Heart and Lung Institute | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Pranav Ravi 614-688-5506 pranav.ravi@oscumc.edu | |
Principal Investigator: Curt Daniels, MD | |
The Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Richard Krasuski, MD 216-445-7430 krasusr@ccf.org | |
Contact: Joseph Parambil, MD 216-445-6024 | |
Principal Investigator: Richard Krasuski, MD | |
Principal Investigator: Joseph Parambil, MD | |
United States, Oklahoma | |
INTEGRIS Baptist Medical Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
Contact: Remzi Bag, MD 405-951-2548 remzi.bag@integris-health.com | |
Principal Investigator: Remzi Bag, MD | |
United States, Oregon | |
The Oregon Clinic | Recruiting |
Portland, Oregon, United States, 97220 | |
Contact: Rhett Cummings, MD 503-963-3030 rcummings@orclinic.com | |
Principal Investigator: Rhett Cummings, MD | |
United States, Pennsylvania | |
Allegheny General Hospital | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Carrie Meligary 412-359-3285 cmelegar@wpahs.org | |
Principal Investigator: Srinivas Murali, MD | |
University of Pittsburgh Medical Center - Presbyterian | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Yvette Mallory 412-692-2769 malloryy@upmc.edu | |
Principal Investigator: Marc Simon, MD | |
United States, Texas | |
Baylor College of Medicine and the Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Aadani Frost, MD 713-798-2400 frost@bcm.tmc.edu | |
Principal Investigator: Aadani Frost, MD | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Elizabaeth Owens 214-645-6489 Elizabeth.Owens@UTSouthwestern.edu | |
Principal Investigator: Fernando Torres, MD | |
United States, Utah | |
Central Utah Clinic, PC | Recruiting |
Provo, Utah, United States, 84604 | |
Contact: Denise Roberts, RN, CRC 801-354-8268 droberts@centralutahclinic.com | |
Contact: Rachel Hill rhill@centralutahclinic.com | |
Principal Investigator: Rodney S. Badger, MD | |
United States, Virginia | |
Sentara Norfolk General Hospital | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Michael Eggert, MD 757-466-5949 msbe@aol.com | |
Principal Investigator: Michael Eggert, MD | |
United States, Wisconsin | |
Medical College of Wisconsin-Frodtert Memorial Lutheran Hospital | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Gary Kung 414-456-7046 gkung@mcw.edu | |
Principal Investigator: Francisco Soto, MD |
Responsible Party: | Actelion ( Lee Golden, MD ) |
Study ID Numbers: | AC-052-419 |
Study First Received: | February 7, 2007 |
Last Updated: | January 29, 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 |