ong-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
Phase 2
Recruiting
- Conditions
- Pulmonary HypertensionC08.381.423
- Registration Number
- RBR-7jcvv4
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Volunteers who participated in the study AMB112529; with diagnosis of Persistent Pulmonary Arterial Hypertension; Male or female;
Exclusion Criteria
Subjects who were withdrawn from ambrisentan in Study AMB112529;subjects with severe renal impairment;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of Ambrisentan in the proposed paediatric Pulmonary Arterial Hypertension population, safety and tolerability wil be assessed by a comparison between two ambrisentan dose groups (low x high). The parameters that will be used are review of display of adverse events, laboratory values, vital signs and pubertal development.The exams will be perfomed during the conduction of the study.
- Secondary Outcome Measures
Name Time Method Obtain supportive efficacy data on the pediatric use of ambrisentan in pulmonary arterial hypertension. The following efficacy evaluation parameters will be included: The change from baseline in the 6 minute walking distance (6MWD) test evaluated after 24 weeks of therapy; Mean changes from baseline in the 6MWD test at weeks 4, 8, 12, 16, and 20; The time to clinical worsening of PAH; The change from baseline in Subject Global Assessment to week 24 using the SF-10 health survey for children; The changes week 24; Change from baseline in plasma from baseline in WHO functional class to N-Terminal pro-B-Type Natriuretic Peptide (NT- Pro BNP)concentration at week 24.