Last updated: 11/07/2018 04:39:40

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

GSK study ID
112300
See study documents
Clinicaltrials.gov ID
NCT01387191
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
Drug: Epoprostenol
Enrollment:
748
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Toru Satoh, Hideyuki Okano, Terufumi Hara. Effectiveness and Safety of Long-term Epoprostenol Treatment in Japanese Patients with Pulmonary Hypertension – Multicenter Prospective Study. Prog Med. 2015;35(8):1333-1341
Medical condition
Cardiovascular Disease
Product
epoprostenol
Collaborators
Not applicable
Study date(s)
August 1999 to July 2009
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
None
  • Subjects with cardiovascular disease
  • Subjects with hypersensitivity to epoprostenol
  • Subjects with right cardiac failure during an acute exacerbation
Inclusion and exclusion criteria
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

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2009-24-07

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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