Last updated: 11/07/2018 11:09:48

Flolan® Article 81, a retrospective observational study of the cohort of pulmonary arterial hypertension patients treated by Expert Centres in Belgium with Flolan® (epoprostenol).Flolan® is a registered trademark of the GlaxoSmithKline group of companies.

GSK study ID
116859
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Flolan® Article 81, a retrospective observational study of the cohort of pulmonary arterial hypertension patients treated by Expert Centres in Belgium with Flolan® (epoprostenol).Flolan® is a registered trademark of the GlaxoSmithKline group of companies.
Trial description: Retrospective observational study carried out in compliance with the requirements of the article 81 convention between GSK and RIZIV/INAMI.
The study includes pulmonary arterial hypertension (PAH) patients in Belgium treated with epoprostenol (Flolan®) within the 2 reference centres (UZ Gasthuisberg, Leuven and Hôpital Erasme, Brussels)
The study will contain clinical data relating to the medical records of the patients, from start of Flolan® treatment till the most recent available follow-up visit. The study covers the period from the beginning of availability of Flolan® in Belgium in 1996 until 30 April 2012, i.e. two years after the start of the Flolan® article 81 convention.
Flolan® is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Clinical benefit

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

Secondary outcomes:

o Hemodynamics (mPAP, CI, PVR, PCWP, RAP)

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o 6 minute walking distance

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o functional status according to NYHA

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o Borg Dyspnoea Index

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o ‘time to clinical worsening’ (based on first occurrence of event in each patient) in PAH-patients

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o the ‘% of patients with ‘clinical worsening’ (based on all events in each patient)

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

o Clinical worsening

Timeframe: at start of Flolan® treatment (baseline), at follow-up visits (approximately 3 months, approx. 6 months, approx. yearly thereafter)

Interventions:
Not applicable
Enrollment:
107
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
M. Delcroix, W. Wuyts, E. Vandevelde, K. Jacobs, M. De Clippel, R. Baptista, J.L. Vachiery.Efficacy of intravenous epoprostenol for pulmonary arterial hypertension in 2 treatment eras..Am J Respir Crit Care Med.2013;187:A3284
Medical condition
Hypertension, Pulmonary
Product
epoprostenol
Collaborators
Not applicable
Study date(s)
June 2012 to June 2012
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
  • Pulmonary Arterial Hypertension
Inclusion and exclusion criteria
Inclusion criteria:
  • Pulmonary Arterial Hypertension

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-30-06

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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