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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Drug: Ambrisentan

Study type: Observational

Funder types: Industry

Identifiers

NCT01406327

114782

Details and patient eligibility

About

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.)

Enrollment: 900 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

900 participants in 1 patient group

Subjects prescribed ambrisentan

Description:

Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period

Treatment:

Drug: Ambrisentan