NCT00581607

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.

Conditions

• Sarcoidosis
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2007-12-27
• Last updated: 2013-04-12

Locations

4 sites across 1 country: United States