Placebo Controlled Trial of Bosentan in Scleroderma Patients
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|ClinicalTrials.gov Identifier: NCT00377455|
Recruitment Status : Terminated (Study was terminated due to inadequate enrolment)
First Posted : September 18, 2006
Results First Posted : July 20, 2011
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Scleroderma Pulmonary Hypertension||Drug: Bosentan Drug: Placebo||Phase 2|
Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of New York Heart Association (NYHA)Class III/IV PAH in scleroderma. Bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in PAH patients (7). Therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with PAH (World Health Organization (WHO) Functional Class I) remains controversial. We hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress Doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe PAH. We further hypothesize that early identification and treatment of such patients may retard the progression of that disease.
- Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis.
- Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis.
Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study, Exercise Echocardiograms in Scleroderma (IRB# 03-363).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||March 2010|
U.S. FDA Resources
62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
|Placebo Comparator: Placebo||
62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
- Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol. [ Time Frame: This will be determined after 16 weeks on the study medication. ]
- 6-minute Walk Distance [ Time Frame: 16 weeks ]The distance walked during a 6-minute walk test.
- Brain Natriuretic Peptide (BNP) Level [ Time Frame: 16 weeks ]Serum BNP level
- Endothelin-1(ET-1) Level [ Time Frame: 16 weeks ]From saved serum
- Quality of Life (QOL) [ Time Frame: 16 weeks ]QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377455
|United States, Connecticut|
|University of Connecticut|
|Farmington, Connecticut, United States, 06030|
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Virginia D Steen, MD||Georgetown University|