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Sponsors and Collaborators: |
University of Cincinnati Actelion |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00581607 |
Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.
Condition | Intervention | Phase |
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Sarcoidosis Pulmonary Arterial Hypertension |
Drug: Bosentan Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bosentan for 16 weeks: Active Comparator
Active drug
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Drug: Bosentan
62.5 mg bid for 4 weeks, then 125 mg bid
Drug: Bosentan
drug given for 16 weeks
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Placebo: Placebo Comparator
Placebo for 16 weeks
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Drug: Placebo
Placebo twice a day
Drug: Placebo
placebo
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Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
Contact: Robert P Baughman, MD | 513-584-5225 | bob.baughman@uc.edu |
Contact: Stacy Harman | 513-584-2196 | stacy.harman@uc.edu |
United States, New York | |
Mount Sinai | Recruiting |
New York, New York, United States | |
Contact: Maria Padilla maria.padilla@mssm.edu | |
Principal Investigator: Maria Padilla | |
Principal Investigator: Alvin Teirstein | |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Contact: Robert P Baughman, MD 513-584-5225 bob.baughman@uc.edu | |
Contact: Elyse E Lower 513-584-3829 ELower@ohcmail.com | |
Sub-Investigator: Peter Engel, MD | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States | |
Contact: Dan Culver CULVERD@ccf.org | |
Principal Investigator: Dan Culver |
Principal Investigator: | Robert P Baughman, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Robert P. Baughman ) |
Study ID Numbers: | BOSAPAH-1, 7-3-22-1 |
Study First Received: | December 26, 2007 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00581607 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sarcoidosis |
Lymphatic Diseases Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Hypertension Vascular Diseases |
Cardiovascular Agents Sarcoidosis Antihypertensive Agents Lymphoproliferative Disorders Bosentan Hypertension |
Vascular Diseases Sarcoidosis Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Bosentan Lymphatic Diseases |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Hypertension |