MedTrace Logo

Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.

NCT01884675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-03-06

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Ambrisentan 5 mg

White, film-coated, immediate-release tablets, containing 5 mg ambrisentan for single dose oral.

DRUG

Placebo

White, film-coated, ambrisentan-matching placebo tablet for single oral dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884675 on ClinicalTrials.gov