Last updated: 11/07/2018 02:53:13
An Observational Study For AmbrisentanVOLT
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
Trial description: The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
safety monitoring
Timeframe: N/A
Secondary outcomes:
safety monitoring
Timeframe: N/A
Interventions:
Drug: ambrisentan
Enrollment:
800
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Vachiery JL, Hoeper M, Peacock A, Sitbon O, Cheli M, Church C, Olsson KM, Palazzini M, Waterhouse B, Langley J, Galie N. Ambrisentan use for pulmonary arterial hypertension (PAH) in a post-authorisation drug registry: The VOLibris Tracking study. J Heart Lung Transplant. 2017;36(4):399-406.
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
GSK
Study date(s)
June 2008 to July 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Inclusion and exclusion criteria
Inclusion criteria:
- subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Trial location(s)
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg, Germany, 74245
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42699
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Study Complete
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Study Complete
Location
GSK Investigational Site
Moers, Nordrhein-Westfalen, Germany, 47441
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chermside, Queensland, Australia, 4032
Status
Study Complete
Location
GSK Investigational Site
Gerlingen, Baden-Wuerttemberg, Germany, 70839
Status
Study Complete
Location
GSK Investigational Site
Donaueschingen, Baden-Wuerttemberg, Germany, 78166
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Study Complete
Location
GSK Investigational Site
Treuenbrietzen, Brandenburg, Germany, 14929
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
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
2013-12-07
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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