BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00367770|
Recruitment Status : Completed
First Posted : August 23, 2006
Results First Posted : August 15, 2016
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Tracleer®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Patients will receive up to 125 mg b.i.d. of Tracleer.
- Change in 6-minute Walk Distance [ Time Frame: from baseline to week 24 ]
- Change in Borg Dyspnea Index [ Time Frame: from baseline to week 24 ]Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
- Number of Participants With a Change in WHO Functional Class [ Time Frame: from baseline to week 24 ]
Number of participants with a change in WHO functional class from baseline to week 24.
A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367770
|Study Chair:||Michael Landzberg, MD||BACH Pulmonary Hypertension Service, Boston, U.S.A.|