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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 : May 24, 2018
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Virginia Steen, MD, Georgetown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Systemic Scleroderma
Pulmonary Hypertension
Interventions Drug: Bosentan
Drug: Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bosentan and Placebo Arms
Hide Arm/Group Description This group consists of subjects on both arms of the study - bosentan and placebo
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Bosentan and Placebo Arms
Hide Arm/Group Description This group consists of subjects on both arms of the study - bosentan and placebo
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.
Hide Description The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.
Time Frame This will be determined after 16 weeks on the study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan/Placebo
Hide Arm/Group Description:
Outcomes not available, due to early termination of study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 6-minute Walk Distance
Hide Description The distance walked during a 6-minute walk test.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcomes not available, due to early termination of study
Arm/Group Title Bosentan/Placebo
Hide Arm/Group Description:
Outcomes not available, due to early termination of study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Brain Natriuretic Peptide (BNP) Level
Hide Description Serum BNP level to evaluate Brain Natriuretic Peptide (BNP) level
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcomes not available, due to early termination of study
Arm/Group Title Bosentan/Placebo
Hide Arm/Group Description:
Outcomes not available, due to early termination of study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Endothelin-1(ET-1) Level
Hide Description From saved serum to determine Endothelian-1 (ET-1) levels in patients
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcomes not available, due to early termination of study
Arm/Group Title Bosentan/Placebo
Hide Arm/Group Description:
Outcomes not available, due to early termination of study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quality of Life (QOL)
Hide Description 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).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcomes not available, due to early termination of study
Arm/Group Title Bosentan/Placebo
Hide Arm/Group Description:
Outcomes not available, due to early termination of study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Serious or Other (non-serious) Adverse Events were collected/assessed, but none observed
 
Arm/Group Title Bosentan and Placebo Arms
Hide Arm/Group Description This group consists of subjects on both arms of the study - bosentan and placebo
All-Cause Mortality
Bosentan and Placebo Arms
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosentan and Placebo Arms
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bosentan and Placebo Arms
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Virginia Steen
Organization: Georgetown University
Phone: 202-444-6200
EMail: steenv@georgetown.edu
Layout table for additonal information
Responsible Party: Virginia Steen, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00377455     History of Changes
Other Study ID Numbers: IRB 06-043
Bosentan ( Other Identifier: Georgetown University )
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: March 28, 2011
Results First Posted: July 20, 2011
Last Update Posted: May 24, 2018