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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00367770 |
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Date of registration:
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21/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
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Scientific title:
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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 |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00367770 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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France
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Germany
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Italy
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Netherlands
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Michael Landzberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BACH Pulmonary Hypertension Service, Boston, U.S.A. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Tracleer®
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Primary Outcome(s)
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Number of Participants With a Change in WHO Functional Class
[Time Frame: from baseline to week 24]
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Change in Borg Dyspnea Index
[Time Frame: from baseline to week 24]
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Change in 6-minute Walk Distance
[Time Frame: from baseline to week 24]
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Secondary ID(s)
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AC-052-409
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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