BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology - Tabular View

Tracking Information
First Received Date ^ICMJE	August 21, 2006
Last Updated Date	November 14, 2006
Start Date ^ICMJE	January 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 22, 2006)	Serious adverse events Adverse events leading to dose reduction, temporary interruption or permanent discontinuation Laboratory tests and oxygen saturation
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00367770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 22, 2006)	Six minute walk test at week 24 Borg dyspnea index at week 24
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Official Title ^ICMJE	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
Brief Summary	This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Arterial Hypertension
Intervention ^ICMJE	Drug: Tracleer® (bosentan)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	December 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study. For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenrrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method. Patients providing written informed consent. Exclusion Criteria: Patients who withdrew prematurely from BREATHE-5, AC-052-405. Patients who are pregnant or nursing Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study. Patients with AST and/or ALT values greater than 3 times the upper limit of normal. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study. Patients with systolic blood pressure < 85 mm Hg Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product Patients active on organ transplant list Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus Patients not able to comply with the protocol or adhere to therapy
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00367770
Responsible Party
Study ID Numbers ^ICMJE	AC-052-409
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Actelion
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP