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A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

NCT00864201 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-03-18

No results posted yet for this study

Summary

The primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. The authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.

Conditions

  • Hypertension, Pulmonary
  • Connective Tissue Disease

Interventions

DRUG

bosentan

bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Christine Bradley · Hamilton Health Sciences Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Canada

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 NCT00864201 on ClinicalTrials.gov