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

This study has been completed.
Information provided by:
Actelion Identifier:
First received: August 21, 2006
Last updated: February 11, 2010
Last verified: November 2006
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Tracleer® (bosentan)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Serious adverse events
  • Adverse events leading to dose reduction, temporary interruption or permanent discontinuation
  • Laboratory tests and oxygen saturation

Secondary Outcome Measures:
  • Six minute walk test at week 24
  • Borg dyspnea index at week 24

Estimated Enrollment: 40
Study Start Date: January 2004
Estimated Study Completion Date: December 2005

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study.
  2. 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.
  3. Patients providing written informed consent.

Exclusion Criteria:

  1. Patients who withdrew prematurely from BREATHE-5, AC-052-405.
  2. Patients who are pregnant or nursing
  3. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
  4. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
  5. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study.
  6. Patients with systolic blood pressure < 85 mm Hg
  7. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product
  8. Patients active on organ transplant list
  9. Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus
  10. Patients not able to comply with the protocol or adhere to therapy
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Please refer to this study by its identifier: NCT00367770

United States, Massachusetts
BACH Pulmonary Hypertension Service
Boston, Massachusetts, United States, 02115
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030-2303
Royal Prince Alfred Hospital - Central Clinical School
Camperdown, Australia, NSW 2050
The Royal Melbourne Hospital
Victoria, Australia, 3050
Universitatsklinikum fur Innere Medizin II
Wien, Austria, AT-1090
UZ Gasthuisberg
Leuven, Belgium, BE-3000
Canada, Alberta
The Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Hospital Necker-Enfants Malades
Paris, France, 75007
Herzzentrum NRW
Bad Oeynhausen, Germany, D-32545
Deutsches Herzzentrum Munchen
Munchen, Germany, D-80636
University of Bologna
Bologna, Italy, 40138
San Matteo Hospital
Pavia, Italy, 27100
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
Unidad Medico Quirurgica de Cardiologia - Edificio General
Madrid, Spain, 28046
United Kingdom
Scottish Vascular Unit - Western Infirmary
Glasgow, United Kingdom, G11 6NT
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
  More Information Identifier: NCT00367770     History of Changes
Other Study ID Numbers: AC-052-409 
Study First Received: August 21, 2006
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Pulmonary Arterial Hypertenstion Related to Eisenmenger Physiology
Pulmonary Arterial Hypertenstion
Eisenmenger Physiology

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Eisenmenger Complex
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on July 25, 2016