Hypertension, PulmonaryVOLTNCT00679224
An Observational Study For Ambrisentan
An observational study of Hypertension, Pulmonary, run by GlaxoSmithKline at 112 sites in 15 countries.
Trial summary
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- ambrisentan
- How many people
- 800 participants
- Where
- 112 sitesin 15 countries
- Study dates
- Jun 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects who have been prescribed ambrisentan for a medically appropriate use. (See approved product label e.g. Summary of Product Characteristics. )
subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Trial locations and contacts
112 sites in 15 countries.
112 sites in 15 countries
Germany29 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 12559
GSK Investigational Site
Berlin, State of Berlin, 12683
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937
GSK Investigational Site
Cottbus, Brandenburg, 03048
GSK Investigational Site
Donaueschingen, Baden-Wurttemberg, 78166
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Gerlingen, Baden-Wurttemberg, 70839
GSK Investigational Site
Giessen, Hesse, 35392
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, 17487
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20246
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69126
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Löwenstein, Baden-Wurttemberg, 74245
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23538
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Moers, North Rhine-Westphalia, 47441
GSK Investigational Site
Munich, Bavaria, 81377
GSK Investigational Site
Regensburg, Bavaria, 93053
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42699
GSK Investigational Site
Treuenbrietzen, Brandenburg, 14929
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89081
France21 sites
GSK Investigational Site
Besançon, 25030
GSK Investigational Site
Bordeaux, 33000
GSK Investigational Site
Brest, 29200
GSK Investigational Site
Bron, 69677
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Clamart, 92140
GSK Investigational Site
Grenoble, 38043
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Marseille, 13385
GSK Investigational Site
Marseille, 13915
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Poitiers, 86021
GSK Investigational Site
Reims, 51092
GSK Investigational Site
Rennes, 35033
GSK Investigational Site
Rouen, 76031
GSK Investigational Site
Strasbourg, 67098
GSK Investigational Site
Toulouse, 31059
GSK Investigational Site
Tours, 37044
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511
Spain11 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Córdoba, 14004
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Ourense, 32005
GSK Investigational Site
Pontevedra, 36071
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Toledo, 45004
GSK Investigational Site
Valencia, 46026
Italy9 sites
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Catania, Sicily, 95100
GSK Investigational Site
Florence, Tuscany, 50139
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Orbassano (TO), Piedmont, 10043
GSK Investigational Site
Palermo, Sicily, 90127
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Pisa, Tuscany, 56124
GSK Investigational Site
Rome, Lazio, 00161
Canada7 sites
GSK Investigational Site
Edmonton, Alberta, T6G 2B7
GSK Investigational Site
Halifax, Nova Scotia, B3H 3A7
GSK Investigational Site
London, Ontario, N6A 5W9
GSK Investigational Site
Montreal, Quebec, H3T 1E2
GSK Investigational Site
Toronto, Ontario, M5G 2N2
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R8
Netherlands7 sites
GSK Investigational Site
Amsterdam, 1081 HV
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Maastricht, 6229 HX
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Nijmegen, 6525 GA
GSK Investigational Site
Rotterdam, 3015 CE
United Kingdom6 sites
GSK Investigational Site
Cambridge, CB3 8RE
GSK Investigational Site
Clydebank, G81 4DY
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, W12 0HS
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN
GSK Investigational Site
Sheffield, S10 2JF
Greece5 sites
GSK Investigational Site
Alexandroupoli, 68100
GSK Investigational Site
Athens, 124 62
GSK Investigational Site
Thessaloniki, 546 36
GSK Investigational Site
Thessaloniki, 57010
GSK Investigational Site
Voula / Athens, 166 73
Sweden5 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Umeå, SE-901 85
GSK Investigational Site
Uppsala, SE-751 85
Australia3 sites
GSK Investigational Site
Chermside, Queensland, 4032
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Melbourne, Victoria, 3004
Belgium2 sites
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Leuven, 3000
Czechia2 sites
GSK Investigational Site
Prague, 128 08
GSK Investigational Site
Prague, 140 00
Norway2 sites
GSK Investigational Site
Bergen, 5021
GSK Investigational Site
Oslo, 0027
Slovakia2 sites
GSK Investigational Site
Bratislava, 833 48
GSK Investigational Site
Košice, 040 11
About this study
Official title: 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
Read the detailed description
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
- Conditions
- Hypertension, Pulmonary
- Being tested
- ambrisentan
- Keywords
- Pulmonary Arterial Hypertesion, observational safety
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambrisentanDrug
ambrisentan
| Study group | Role | What they receive |
|---|---|---|
| ambrisentan prescribed subjects | ambrisentan prescribed subjects Receives: Drug: ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety monitoring
Secondary outcomes (1)
safety monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679224
- Sponsor's protocol ID
- 110094
- Acronym
- VOLT
- Status last verified
- Mar 2017
- First submitted
- 14 May 2008
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
- ClinicalTrials.gov ID
- NCT00679224
- Acronym / sponsor ID
- VOLT / 110094
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary Arterial Hypertesion, observational safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Detailed description
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambrisentan prescribed subjects | – | Drug: ambrisentanambrisentan prescribed subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects who have been prescribed ambrisentan for a medically appropriate use. (See approved product label e.g. Summary of Product Characteristics. )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ambrisentanambrisentan | Drug | ambrisentan prescribed subjects |
Primary outcome
safety monitoring
1 secondary outcome
safety monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
112 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by GlaxoSmithKline at 112 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in Germany, France, Spain, Italy, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety monitoring. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017; AzTrials last refreshed its copy on 28 Oct 2026.