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Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: bosentan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actelion

Summary

This is a multicenter, multinational, open label, non-comparative, phase III extension study to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension.

Clinical Details

Official title: An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed AC-052-365 (Future 1)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Treatment-emergent adverse events

Adverse events leading to premature discontinuation of study drug

Serious adverse events

Changes from Baseline in vital signs, body weight, and height

Treatment-emergent marked laboratory abnormalities

Secondary outcome: Change from Baseline from FUTURE 1 of WHO functional class, quality of life questionnaire, Global Clinical Impression Scale according to parents/legal guardians and physician

Eligibility

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent by the parents or the legal representatives.

- Patients who completed the FUTURE 1 study.

- Patients who tolerated bosentan pediatric formulation and for whom bosentan is

considered beneficial at the end of FUTURE 1.

- Males or females >= 2 and < 12 years of age at enrollment in FUTURE 2 (this study).

Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate. Exclusion Criteria:

- Intolerance to bosentan despite dose reductions.

- Any clinically significant laboratory abnormality that precludes continuation of

bosentan therapy.

- Pregnancy or breast-feeding.

- Known hypersensitivity to bosentan or any of the excipients.

- Premature and permanent study drug discontinuation during FUTURE 1.

Locations and Contacts

Hopital Antoine Beclere, Clamart 92140, France

Hopital Necker, Paris 75743, France

CHE de Toulouse Hopital d'Enfants, Toulouse, France

Deutsches Herzzentrum, Augustenburger, Germany

Universitats Kinderklinik, Giessen, Germany

Policlinico S. Orsola-Malpighi, Bologna 40138, Italy

Beatrix Children's Hospital, Groningen, Netherlands

Hopital des Enfants, Geneva, Switzerland

The Institute of Child Health, London, United Kingdom

The Children's Hospital Cardiac Care Center, Denver, Colorado 80218, United States

Columbia University Medical Center, New York, New York 10032, United States

Additional Information

Starting date: August 2005
Last updated: April 8, 2013

Page last updated: August 23, 2015

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