Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

GlaxoSmithKline900 enrolled

Overview

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.)

Study Type

OBSERVATIONAL

Enrollment

900

Conditions

Hypertension, Pulmonary

Interventions

AmbrisentanDRUG

Ambrisentan

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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