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Trial record 1 of 4 for:    BREATHE-5
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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. Identifier: NCT00367770
Recruitment Status : Completed
First Posted : August 23, 2006
Results First Posted : August 15, 2016
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Tracleer® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in 6-minute Walk Distance [ Time Frame: from baseline to week 24 ]
  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00367770

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Sponsors and Collaborators
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Study Chair: Michael Landzberg, MD BACH Pulmonary Hypertension Service, Boston, U.S.A.
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Responsible Party: Actelion Identifier: NCT00367770    
Other Study ID Numbers: AC-052-409
First Posted: August 23, 2006    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: September 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Actelion:
PAH related to Eisenmenger physiology
Additional relevant MeSH terms:
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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