A clinical study to evaluate the efficacy and safety of Ambrisentan on Pulmonary Arterial Hypertension in patients aged 8 years up to 18 years

Phase 2

Suspended

• Conditions: Pulmonary hypertension; C08.381.423

• Registration Number: RBR-8vvwj8
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

66 Volunteers with diagnosis of Persistent Pulmonary Arterial Hypertension; Male or female; at least 8 years of age and not yet 18 years of age

Exclusion Criteria

Volunteers currently taking an endothelin receptor antagonist or cyclosporine A and whose body weight is less than 20 Kg

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

Secondary Outcome Measures

Name	Time	Method
Obtain supportive efficacy dataon the paediatric use of Ambrisentan in Pulmonary Arterial Hypertension