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

AMB112529 - A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of Ambrisentan (adjusted for body weight) for the treatment of Pulmonary Arterial Hypertension in paediatric patients aged 8 years up to 18 years

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8vvwj8

Enrollment

Unknown

Registered

2016-07-05

Start date

2011-01-04

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension

Interventions

Arm 1: 33 patients on low dose group receiving Ambrisentan, dose 2.5mg to 5mg once daily according to body weight, for at least 24 weeks Arm 2: 33 patients on high dose group receiving Ambrisentan, d

Drug

N02.421.668.438

Eligibility

Age

8 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of Ambrisentan in the proposed paediatric Pulmonary Arterial Hypertension population	—

Secondary

Measure	Time frame
Obtain supportive efficacy dataon the paediatric use of Ambrisentan in Pulmonary Arterial Hypertension	—

Countries

Argentina, Brazil, Canada, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Russian Federation, Spain, United States

Contacts

Public ContactPesquisador Responsável - Contato Público

GlaxoSmithKline Brasil

sac.brasil@gsk.com+55 21 21416000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)