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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00679224




Registration number
NCT00679224
Ethics application status
Date submitted
14/05/2008
Date registered
16/05/2008
Date last updated
23/03/2017

Titles & IDs
Public title
An Observational Study For Ambrisentan
Scientific title
A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
Secondary ID [1] 0 0
110094
Universal Trial Number (UTN)
Trial acronym
VOLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - ambrisentan

ambrisentan prescribed subjects - ambrisentan prescribed subjects


Treatment: Drugs: ambrisentan
ambrisentan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
safety monitoring
Timepoint [1] 0 0
Secondary outcome [1] 0 0
safety monitoring
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
subjects who have been prescribed ambrisentan for a medically appropriate use (see approved
product label)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
800
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha 2
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 4
Country [11] 0 0
Denmark
State/province [11] 0 0
Aarhus N
Country [12] 0 0
France
State/province [12] 0 0
Besançon
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Brest
Country [15] 0 0
France
State/province [15] 0 0
Bron
Country [16] 0 0
France
State/province [16] 0 0
Caen Cedex 5
Country [17] 0 0
France
State/province [17] 0 0
Clamart
Country [18] 0 0
France
State/province [18] 0 0
Grenoble
Country [19] 0 0
France
State/province [19] 0 0
Lille cedex
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Marseille cedex 20
Country [22] 0 0
France
State/province [22] 0 0
Marseille cedex 5
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Nantes cedex 1
Country [25] 0 0
France
State/province [25] 0 0
Pessac cedex
Country [26] 0 0
France
State/province [26] 0 0
Poitiers cedex
Country [27] 0 0
France
State/province [27] 0 0
Reims
Country [28] 0 0
France
State/province [28] 0 0
Rennes cedex 9
Country [29] 0 0
France
State/province [29] 0 0
Rouen Cedex
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
France
State/province [32] 0 0
Tours cedex 9
Country [33] 0 0
France
State/province [33] 0 0
Vandoeuvre-Les-Nancy
Country [34] 0 0
Germany
State/province [34] 0 0
Baden-Wuerttemberg
Country [35] 0 0
Germany
State/province [35] 0 0
Bayern
Country [36] 0 0
Germany
State/province [36] 0 0
Brandenburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hessen
Country [38] 0 0
Germany
State/province [38] 0 0
Mecklenburg-Vorpommern
Country [39] 0 0
Germany
State/province [39] 0 0
Niedersachsen
Country [40] 0 0
Germany
State/province [40] 0 0
Nordrhein-Westfalen
Country [41] 0 0
Germany
State/province [41] 0 0
Rheinland-Pfalz
Country [42] 0 0
Germany
State/province [42] 0 0
Sachsen
Country [43] 0 0
Germany
State/province [43] 0 0
Schleswig-Holstein
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Hamburg
Country [46] 0 0
Greece
State/province [46] 0 0
Alexandroupolis
Country [47] 0 0
Greece
State/province [47] 0 0
Athens
Country [48] 0 0
Greece
State/province [48] 0 0
Thessaloniki
Country [49] 0 0
Greece
State/province [49] 0 0
Voula / Athens
Country [50] 0 0
Italy
State/province [50] 0 0
Campania
Country [51] 0 0
Italy
State/province [51] 0 0
Emilia-Romagna
Country [52] 0 0
Italy
State/province [52] 0 0
Lazio
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Piemonte
Country [55] 0 0
Italy
State/province [55] 0 0
Sicilia
Country [56] 0 0
Italy
State/province [56] 0 0
Toscana
Country [57] 0 0
Netherlands
State/province [57] 0 0
Amsterdam
Country [58] 0 0
Netherlands
State/province [58] 0 0
Groningen
Country [59] 0 0
Netherlands
State/province [59] 0 0
Maastricht
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nieuwegein
Country [61] 0 0
Netherlands
State/province [61] 0 0
Nijmegen
Country [62] 0 0
Netherlands
State/province [62] 0 0
Rotterdam
Country [63] 0 0
Norway
State/province [63] 0 0
Bergen
Country [64] 0 0
Norway
State/province [64] 0 0
Oslo
Country [65] 0 0
Slovakia
State/province [65] 0 0
Bratislava
Country [66] 0 0
Slovakia
State/province [66] 0 0
Kosice
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Córdoba
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Malaga
Country [71] 0 0
Spain
State/province [71] 0 0
Ourense
Country [72] 0 0
Spain
State/province [72] 0 0
Pontevedra
Country [73] 0 0
Spain
State/province [73] 0 0
Sevilla
Country [74] 0 0
Spain
State/province [74] 0 0
Toledo
Country [75] 0 0
Spain
State/province [75] 0 0
Valencia
Country [76] 0 0
Sweden
State/province [76] 0 0
Göteborg
Country [77] 0 0
Sweden
State/province [77] 0 0
Linköping
Country [78] 0 0
Sweden
State/province [78] 0 0
Lund
Country [79] 0 0
Sweden
State/province [79] 0 0
Umeå
Country [80] 0 0
Sweden
State/province [80] 0 0
Uppsala
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cambridge
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Clydebank
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Newcastle upon Tyne
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the programme is to collect safety data on ambrisentan when used in clinical
practice
Trial website
https://clinicaltrials.gov/ct2/show/NCT00679224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00679224