Who is sponsoring AMBER I?

AMBER I is sponsored by GlaxoSmithKline.

What drugs are being tested in AMBER I?

Interventions: Ambrisentan 5 mg, Placebo.

What is the status of AMBER I?

AMBER I is currently TERMINATED.

Last reviewed 2017-01-20 · How we verify

A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). (AMBER I)

NCT01884675 Phase 3 TERMINATED Results posted

It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	TERMINATED
Enrolment	33
Start date	2013-09
Completion	2015-03

Conditions

Hypertension

Interventions

Ambrisentan 5 mg
Placebo

Primary outcomes

Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 — Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal
The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by \<10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant.

Countries

United States, Argentina, Austria, Canada, China, Czechia, Germany, Israel, Japan, Mexico, Netherlands, Russia, Saudi Arabia, South Korea, Spain, United Kingdom