Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
- Registration Number
- NCT01387191
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;
1. Unknown adverse reactions (especially, significant adverse reactions)
2. Adverse reaction onset status under practical drug use conditions
3. Factors possibly influential on safety
4. Factors possibly influential on efficacy
5. Patient's prognosis, efficacy and safety in long-term use
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 748
Inclusion Criteria
- Subjects with cardiovascular disease
Exclusion Criteria
- Subjects with hypersensitivity to epoprostenol
- Subjects with right cardiac failure during an acute exacerbation
- Subjects with severe left ventricular systolic dysfunction
- Subjects with serious left ventricular dysfunction
- Subjects whose pulmonary edema getting worse during dose initiation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects prescribed epoprostenol Epoprostenol Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period
- Primary Outcome Measures
Name Time Method The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection 12 weeks
- Secondary Outcome Measures
Name Time Method