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

NCT ID: NCT00367770

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-12-31

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

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tracleer®

Intervention Type: DRUG

Patients will receive up to 125 mg b.i.d. of Tracleer.

Interventions

Tracleer®

Patients will receive up to 125 mg b.i.d. of Tracleer.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Landzberg, MD

Role: STUDY_CHAIR

BACH Pulmonary Hypertension Service, Boston, U.S.A.

Locations

BACH Pulmonary Hypertension Service

Boston, Massachusetts, United States

Texas Children's Hospital

Houston, Texas, United States

Royal Prince Alfred Hospital - Central Clinical School

Camperdown, , Australia

The Royal Melbourne Hospital

Victoria, , Australia

Universitatsklinikum fur Innere Medizin II

Vienna, , Austria

UZ Gasthuisberg

Leuven, , Belgium

The Peter Lougheed Centre

Calgary, Alberta, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Hospital Necker-Enfants Malades

Paris, , France

Herzzentrum NRW

Bad Oeynhausen, , Germany

Deutsches Herzzentrum Munchen

München, , Germany

University of Bologna

Bologna, , Italy

San Matteo Hospital

Pavia, , Italy

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

Unidad Medico Quirurgica de Cardiologia - Edificio General

Madrid, , Spain

Scottish Vascular Unit - Western Infirmary

Glasgow, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; France; Germany; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

AC-052-409

Identifier Type: -

Identifier Source: org_study_id