Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
- Registration Number
- NCT01406327
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects prescribed ambrisentan Ambrisentan Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
- Primary Outcome Measures
Name Time Method The number of adverse events and clinical course in subjects with hepatic dysfunction 1 year The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan 1 year The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage 1 year
- Secondary Outcome Measures
Name Time Method