An Observational Study For Ambrisentan (VOLT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679224
First received: May 14, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice


Condition Intervention
Hypertension, Pulmonary
Drug: ambrisentan

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • safety monitoring [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety monitoring [ Designated as safety issue: Yes ]

Enrollment: 800
Study Start Date: June 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ambrisentan prescribed subjects
ambrisentan prescribed subjects
Drug: ambrisentan
ambrisentan

Detailed Description:

The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

subjects who have been prescribed ambrisentan for a medically appropriate use. (See approved product label e.g. Summary of Product Characteristics. )

Criteria

subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679224

  Hide Study Locations
Locations
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
GSK Investigational Site
Chermside, Queensland, Australia, 4032
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Belgium
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Leuven, Belgium, 3000
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R8
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
GSK Investigational Site
London, Ontario, Canada, N6A 5W9
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
GSK Investigational Site
Praha 2, Czech Republic, 128 08
GSK Investigational Site
Praha 4, Czech Republic, 140 00
Denmark
GSK Investigational Site
Aarhus N, Denmark, DK-8200
France
GSK Investigational Site
Besançon, France, 25030
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Brest, France, 29200
GSK Investigational Site
Bron, France, 69677
GSK Investigational Site
Caen Cedex 5, France, 14033
GSK Investigational Site
Clamart, France, 92140
GSK Investigational Site
Grenoble, France, 38043
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Lille cedex, France, 59037
GSK Investigational Site
Marseille cedex 20, France, 13915
GSK Investigational Site
Marseille cedex 5, France, 13385
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Nantes cedex 1, France, 44093
GSK Investigational Site
Pessac cedex, France, 33604
GSK Investigational Site
Poitiers cedex, France, 86021
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Rennes cedex 9, France, 35033
GSK Investigational Site
Rouen Cedex, France, 76031
GSK Investigational Site
Strasbourg, France, 67098
GSK Investigational Site
Toulouse, France, 31059
GSK Investigational Site
Tours cedex 9, France, 37044
GSK Investigational Site
Vandoeuvre-Les-Nancy, France, 54511
Germany
GSK Investigational Site
Donaueschingen, Baden-Wuerttemberg, Germany, 78166
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Gerlingen, Baden-Wuerttemberg, Germany, 70839
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg, Germany, 74245
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Muenchen, Bayern, Germany, 81377
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03048
GSK Investigational Site
Treuenbrietzen, Brandenburg, Germany, 14929
GSK Investigational Site
Giessen, Hessen, Germany, 35392
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
GSK Investigational Site
Moers, Nordrhein-Westfalen, Germany, 47441
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42699
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 12683
GSK Investigational Site
Berlin, Germany, 12559
GSK Investigational Site
Hamburg, Germany, 20246
Greece
GSK Investigational Site
Alexandroupolis, Greece, 68100
GSK Investigational Site
Athens, Greece, 124 62
GSK Investigational Site
Thessaloniki, Greece, 57010
GSK Investigational Site
Thessaloniki, Greece, 546 36
GSK Investigational Site
Voula / Athens, Greece, 166 73
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Roma, Lazio, Italy, 00161
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
GSK Investigational Site
Catania, Sicilia, Italy, 95100
GSK Investigational Site
Palermo, Sicilia, Italy, 90127
GSK Investigational Site
Firenze, Toscana, Italy, 50139
GSK Investigational Site
Pisa, Toscana, Italy, 56124
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
Norway
GSK Investigational Site
Bergen, Norway, 5021
GSK Investigational Site
Oslo, Norway, 0027
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 833 48
GSK Investigational Site
Kosice, Slovakia, 040 11
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Córdoba, Spain, 14004
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Ourense, Spain, 32005
GSK Investigational Site
Pontevedra, Spain, 36071
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Toledo, Spain, 45004
GSK Investigational Site
Valencia, Spain, 46026
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Linköping, Sweden, SE-581 85
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Uppsala, Sweden, SE-751 85
United Kingdom
GSK Investigational Site
Cambridge, United Kingdom, CB3 8RE
GSK Investigational Site
Clydebank, United Kingdom, G81 4DY
GSK Investigational Site
London, United Kingdom, W12 0HS
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679224     History of Changes
Other Study ID Numbers: 110094
Study First Received: May 14, 2008
Last Updated: November 7, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Pulmonary Arterial Hypertesion
observational safety

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014