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Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

NCT00581607 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-04-12

No results posted yet for this study

Summary

Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.

Conditions

Interventions

DRUG

Bosentan

62.5 mg bid for 4 weeks, then 125 mg bid

DRUG

Placebo

Placebo twice a day

DRUG

Bosentan

drug given for 16 weeks

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Robert P Baughman, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00581607 on ClinicalTrials.gov