Overview

This trial is active, not recruiting.

Condition hypertension, pulmonary
Treatment ambrisentan
Sponsor GlaxoSmithKline
Start date December 2010
End date August 2020
Trial size 900 participants
Trial identifier NCT01406327, 114782

Summary

The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;

1. Unknown adverse drug reactions (ADRs)

2. Incidence of ADRs to medical products in actual clinical practice

3. Factors influencing safety of ambrisentan

4. Factors influencing efficacy of ambrisentan

5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan
time frame: 1 year
The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage
time frame: 1 year
The number of adverse events and clinical course in subjects with hepatic dysfunction
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Must use ambrisentan for the first time Exclusion Criteria: - Subjects with hypersensitivity to ambrisentan - Subjects who is pregnant or might be pregnant - Subjects with severe hepatic disorder

Additional Information

Official title Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.