A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) — AMBER II  

Hypertension Clinical Trial

Official title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Status Completed

Clinical Trial Summary

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following:

• The product is approved locally for use in inoperable CTEPH patients;

• Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities

• The investigator decides to discontinue the subject or subject decides to discontinue from the study.

The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

• NCT number: NCT01894022
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Completion date: November 2015