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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387191
• Other study ID #: 112300
• Status: Completed
• Phase: N/A
• First received: June 30, 2011
• Last updated: May 15, 2017
• Start date: August 1999
• Est. completion date: July 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Epoprostenol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

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