Hypertension, Pulmonary
Conditions
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.)
Interventions
DRUGAmbrisentan
Ambrisentan
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| The number of adverse events and clinical course in subjects with hepatic dysfunction | 1 year |
Outcome results
None listed