AMB116457: An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Phase 3

Completed

• Conditions: CTEPH; 10037454; chronic thromboembolic pulmonary hypertension

• Registration Number: NL-OMON38441
• Lead Sponsor: GlaxoSmithKline BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

* Male and female patients with inoperable CTEPH, who have completed the week 16 visit of AMB115811 or who prematurely withdrew for whatever reason. Capable of giving informed consent.

Exclusion Criteria

* Pregnancy or breastfeeding. Non compliance with contraceptive measures from AMB115811.
* Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB115811.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>6 minute walk test, WHO functional class, Borg CR10 scale, clinical worsening<br /><br>of CTEPH, co-medication, NT-proBNP, SF-36 questionnaire.</p><br>