Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00367770
First received: August 21, 2006
Last updated: August 16, 2016
Last verified: July 2016
  Purpose
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®
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:
  • Change in 6-minute Walk Distance [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in Borg Dyspnea Index [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 37
Study Start Date: January 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tracleer
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.
Drug: Tracleer®
Patients will receive up to 125 mg b.i.d. of Tracleer.

Detailed Description:
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.
  Eligibility

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

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 amenorrheic 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367770

Locations
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
Australia
Royal Prince Alfred Hospital - Central Clinical School
Camperdown, Australia, NSW 2050
The Royal Melbourne Hospital
Victoria, Australia, 3050
Austria
Universitatsklinikum fur Innere Medizin II
Wien, Austria, AT-1090
Belgium
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
France
Hospital Necker-Enfants Malades
Paris, France, 75007
Germany
Herzzentrum NRW
Bad Oeynhausen, Germany, D-32545
Deutsches Herzzentrum Munchen
Munchen, Germany, D-80636
Italy
University of Bologna
Bologna, Italy, 40138
San Matteo Hospital
Pavia, Italy, 27100
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
Spain
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
Actelion
Investigators
Study Chair: Michael Landzberg, MD BACH Pulmonary Hypertension Service, Boston, U.S.A.
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00367770     History of Changes
Other Study ID Numbers: AC-052-409 
Study First Received: August 21, 2006
Results First Received: April 11, 2016
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Actelion:
bosentan
PAH related to Eisenmenger physiology
Tracleer

Additional relevant MeSH terms:
Hypertension
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
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016