Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01387191

Enrollment

748

Registered

2011-07-04

Start date

1999-08-31

Completion date

2009-07-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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

Interventions

DRUGEpoprostenol

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026