Placebo Controlled Trial of Bosentan in Scleroderma Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00377455
• Date of registration: 14/09/2006
• Prospective Registration: No
• Primary sponsor: Georgetown University
• Public title: Placebo Controlled Trial of Bosentan in Scleroderma Patients
• Scientific title: Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension
• Date of first enrolment: September 2006
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00377455
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Virginia D Steen, MD
• Affiliation: Georgetown University

Key inclusion & exclusion criteria

Inclusion Criteria:

- SSc patients > 18 with NYHA functional Class I/II symptoms, informed consent, and who
are willing to participate in the Pulmonary Hypertension Assessment and Recognition of
Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)

- Right heart catheterization with

1. Normal Mean Pulmonary Arterial Pressure (PAP) at rest

2. Mean PAP > 30 with exercise

3. Wedge Pressure < 18

- Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB
03-363)

1. Diffusing Capacity (DLCO) <60 with a Forced Vital Capacity (FVC) >60%, or

2. FVC/DLCO > 1.6, or

3. a resting Pulmonary Arterial Systolic Pressure (PASP)> 40mmHg

Exclusion Criteria:

- Established resting pulmonary hypertension

- Congestive heart failure

- Diastolic dysfunction

- Pregnancy

- Inability to adequately walk/exercise

- Severe liver disease



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Systemic Scleroderma

Intervention(s)

Drug: Bosentan

Drug: Placebo

Primary Outcome(s)

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.]

Secondary Outcome(s)

Quality of Life (QOL) [Time Frame: 16 weeks]

6-minute Walk Distance [Time Frame: 16 weeks]

Brain Natriuretic Peptide (BNP) Level [Time Frame: 16 weeks]

Endothelin-1(ET-1) Level [Time Frame: 16 weeks]

Secondary ID(s)

Bosentan

IRB 06-043

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Actelion

Results

• Results available: Yes
• Date Posted: 20/07/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00377455