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

NCT00367770 | Completed Phase 4 Results

• 1 other identifier: AC-052-409
• Study Type: interventional
• Target: 37
• Locations: 10 countries
• Sites: 16

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

bosentan; PAH related to Eisenmenger physiology; Tracleer

Outcome Measures

Primary Outcomes (3)

• Change in 6-minute Walk Distance

  from baseline to week 24

• Change in Borg Dyspnea Index

  Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.

  from baseline to week 24

• Number of Participants With a Change in WHO Functional Class

  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.

  from baseline to week 24

Study Arms (1)

Tracleer

EXPERIMENTAL

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®

Interventions

Tracleer® DRUG

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

Tracleer

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Actelion: lead

Study Sites (17)

BACH Pulmonary Hypertension Service

Boston, Massachusetts, 02115, United States

Location

Texas Children's Hospital

Houston, Texas, 77030-2303, United States

Location

Royal Prince Alfred Hospital - Central Clinical School

Camperdown, NSW 2050, Australia

Location

The Royal Melbourne Hospital

Victoria, 3050, Australia

Location

Universitatsklinikum fur Innere Medizin II

Vienna, AT-1090, Austria

Location

UZ Gasthuisberg

Leuven, BE-3000, Belgium

Location

The Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hospital Necker-Enfants Malades

Paris, 75007, France

Location

Herzzentrum NRW

Bad Oeynhausen, D-32545, Germany

Location

Deutsches Herzzentrum Munchen

München, D-80636, Germany

Location

University of Bologna

Bologna, 40138, Italy

Location

San Matteo Hospital

Pavia, 27100, Italy

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 GZ, Netherlands

Location

Unidad Medico Quirurgica de Cardiologia - Edificio General

Madrid, 28046, Spain

Location

Scottish Vascular Unit - Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Loïc Perchenet, Head of Global Post-Approval Studies
• Organization: Actelion Pharmaceuticals Ltd.

loic.perchenet@actelion.com

+41 61 565 64 57

Study Officials

• Michael Landzberg, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 23, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 22, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DE (2); NL (1); FR (1); US (2); AU (2); ES (1); CA (2); GB (2); IT (2)