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Placebo Controlled Trial of Bosentan in Scleroderma Patients

NCT00377455 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-05-24

Study results available
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Summary

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

Conditions

  • Systemic Scleroderma
  • Pulmonary Hypertension

Interventions

DRUG

Bosentan

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

DRUG

Placebo

62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Virginia D Steen, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377455 on ClinicalTrials.gov