An Observational Study For Ambrisentan (VOLT)

March 21, 2017 updated by: GlaxoSmithKline

A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • GSK Investigational Site
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • GSK Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R8
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • GSK Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2N2
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
  • Czech Republic
      • Praha 2, Czech Republic, 128 08
        • GSK Investigational Site
      • Praha 4, Czech Republic, 140 00
        • GSK Investigational Site
  • Denmark
      • Aarhus N, Denmark, DK-8200
        • GSK Investigational Site
  • France
      • 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
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 12559
        • GSK Investigational Site
      • Berlin, Germany, 12683
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • 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, 69120
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69126
        • 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
    • Bayern
      • Muenchen, Bayern, Germany, 81377
        • GSK Investigational Site
      • Regensburg, Bayern, Germany, 93053
        • GSK Investigational Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • GSK Investigational Site
      • Treuenbrietzen, Brandenburg, Germany, 14929
        • GSK Investigational Site
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17487
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • GSK Investigational Site
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • GSK Investigational Site
  • Greece
      • 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
        • GSK Investigational Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00161
        • GSK Investigational Site
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Piemonte
      • Orbassano (TO), Piemonte, Italy, 10043
        • GSK Investigational Site
    • Sicilia
      • Catania, Sicilia, Italy, 95100
        • GSK Investigational Site
      • Palermo, Sicilia, Italy, 90127
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • GSK Investigational Site
      • Pisa, Toscana, Italy, 56124
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1081 HV
        • 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
        • GSK Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • GSK Investigational Site
      • Oslo, Norway, 0027
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 48
        • GSK Investigational Site
      • Kosice, Slovakia, 040 11
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Córdoba, Spain, 14004
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • 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
        • GSK Investigational Site
  • Sweden
      • 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
        • GSK Investigational Site
  • United Kingdom
      • 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
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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. )

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ambrisentan prescribed subjects
Drug: ambrisentan
ambrisentan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
safety monitoring

Secondary Outcome Measures

Outcome Measure
safety monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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