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VOLT: An Observational Study For Ambrisentan

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00679224
Collaborator
(none)
800
Enrollment
113
Locations
61
Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
800 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
ambrisentan prescribed subjects

ambrisentan prescribed subjects

Drug: ambrisentan
ambrisentan

Outcome Measures

Primary Outcome Measures

  1. safety monitoring []

Secondary Outcome Measures

  1. safety monitoring []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Darlinghurst New South Wales Australia 2010
2 GSK Investigational Site Chermside Queensland Australia 4032
3 GSK Investigational Site Melbourne Victoria Australia 3004
4 GSK Investigational Site Brussels Belgium 1070
5 GSK Investigational Site Leuven Belgium 3000
6 GSK Investigational Site Edmonton Alberta Canada T6G 2B7
7 GSK Investigational Site Vancouver British Columbia Canada V5Z 1M9
8 GSK Investigational Site Winnipeg Manitoba Canada R3A 1R8
9 GSK Investigational Site Halifax Nova Scotia Canada B3H 3A7
10 GSK Investigational Site London Ontario Canada N6A 5W9
11 GSK Investigational Site Toronto Ontario Canada M5G 2N2
12 GSK Investigational Site Montreal Quebec Canada H3T 1E2
13 GSK Investigational Site Praha 2 Czech Republic 128 08
14 GSK Investigational Site Praha 4 Czech Republic 140 00
15 GSK Investigational Site Aarhus N Denmark DK-8200
16 GSK Investigational Site Besançon France 25030
17 GSK Investigational Site Bordeaux France 33000
18 GSK Investigational Site Brest France 29200
19 GSK Investigational Site Bron France 69677
20 GSK Investigational Site Caen Cedex 5 France 14033
21 GSK Investigational Site Clamart France 92140
22 GSK Investigational Site Grenoble France 38043
23 GSK Investigational Site Lille cedex France 59037
24 GSK Investigational Site Lille France 59037
25 GSK Investigational Site Marseille cedex 20 France 13915
26 GSK Investigational Site Marseille cedex 5 France 13385
27 GSK Investigational Site Montpellier France 34295
28 GSK Investigational Site Nantes cedex 1 France 44093
29 GSK Investigational Site Pessac cedex France 33604
30 GSK Investigational Site Poitiers cedex France 86021
31 GSK Investigational Site Reims France 51092
32 GSK Investigational Site Rennes cedex 9 France 35033
33 GSK Investigational Site Rouen Cedex France 76031
34 GSK Investigational Site Strasbourg France 67098
35 GSK Investigational Site Toulouse France 31059
36 GSK Investigational Site Tours cedex 9 France 37044
37 GSK Investigational Site Vandoeuvre-Les-Nancy France 54511
38 GSK Investigational Site Donaueschingen Baden-Wuerttemberg Germany 78166
39 GSK Investigational Site Freiburg Baden-Wuerttemberg Germany 79106
40 GSK Investigational Site Gerlingen Baden-Wuerttemberg Germany 70839
41 GSK Investigational Site Heidelberg Baden-Wuerttemberg Germany 69120
42 GSK Investigational Site Heidelberg Baden-Wuerttemberg Germany 69126
43 GSK Investigational Site Loewenstein Baden-Wuerttemberg Germany 74245
44 GSK Investigational Site Mannheim Baden-Wuerttemberg Germany 68167
45 GSK Investigational Site Ulm Baden-Wuerttemberg Germany 89081
46 GSK Investigational Site Muenchen Bayern Germany 81377
47 GSK Investigational Site Regensburg Bayern Germany 93053
48 GSK Investigational Site Cottbus Brandenburg Germany 03048
49 GSK Investigational Site Treuenbrietzen Brandenburg Germany 14929
50 GSK Investigational Site Giessen Hessen Germany 35392
51 GSK Investigational Site Greifswald Mecklenburg-Vorpommern Germany 17487
52 GSK Investigational Site Hannover Niedersachsen Germany 30625
53 GSK Investigational Site Aachen Nordrhein-Westfalen Germany 52074
54 GSK Investigational Site Essen Nordrhein-Westfalen Germany 45122
55 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 50937
56 GSK Investigational Site Moers Nordrhein-Westfalen Germany 47441
57 GSK Investigational Site Solingen Nordrhein-Westfalen Germany 42699
58 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55131
59 GSK Investigational Site Dresden Sachsen Germany 01307
60 GSK Investigational Site Leipzig Sachsen Germany 04103
61 GSK Investigational Site Grosshansdorf Schleswig-Holstein Germany 22927
62 GSK Investigational Site Luebeck Schleswig-Holstein Germany 23538
63 GSK Investigational Site Berlin Germany 10117
64 GSK Investigational Site Berlin Germany 12559
65 GSK Investigational Site Berlin Germany 12683
66 GSK Investigational Site Hamburg Germany 20246
67 GSK Investigational Site Alexandroupolis Greece 68100
68 GSK Investigational Site Athens Greece 124 62
69 GSK Investigational Site Thessaloniki Greece 546 36
70 GSK Investigational Site Thessaloniki Greece 57010
71 GSK Investigational Site Voula / Athens Greece 166 73
72 GSK Investigational Site Napoli Campania Italy 80131
73 GSK Investigational Site Bologna Emilia-Romagna Italy 40138
74 GSK Investigational Site Roma Lazio Italy 00161
75 GSK Investigational Site Pavia Lombardia Italy 27100
76 GSK Investigational Site Orbassano (TO) Piemonte Italy 10043
77 GSK Investigational Site Catania Sicilia Italy 95100
78 GSK Investigational Site Palermo Sicilia Italy 90127
79 GSK Investigational Site Firenze Toscana Italy 50139
80 GSK Investigational Site Pisa Toscana Italy 56124
81 GSK Investigational Site Amsterdam Netherlands 1081 HV
82 GSK Investigational Site Amsterdam Netherlands 1105 AZ
83 GSK Investigational Site Groningen Netherlands 9713 GZ
84 GSK Investigational Site Maastricht Netherlands 6229 HX
85 GSK Investigational Site Nieuwegein Netherlands 3435 CM
86 GSK Investigational Site Nijmegen Netherlands 6525 GA
87 GSK Investigational Site Rotterdam Netherlands 3015 CE
88 GSK Investigational Site Bergen Norway 5021
89 GSK Investigational Site Oslo Norway 0027
90 GSK Investigational Site Bratislava Slovakia 833 48
91 GSK Investigational Site Kosice Slovakia 040 11
92 GSK Investigational Site Barcelona Spain 08035
93 GSK Investigational Site Barcelona Spain 08036
94 GSK Investigational Site Córdoba Spain 14004
95 GSK Investigational Site Madrid Spain 28034
96 GSK Investigational Site Madrid Spain 28041
97 GSK Investigational Site Malaga Spain 29010
98 GSK Investigational Site Ourense Spain 32005
99 GSK Investigational Site Pontevedra Spain 36071
100 GSK Investigational Site Sevilla Spain 41013
101 GSK Investigational Site Toledo Spain 45004
102 GSK Investigational Site Valencia Spain 46026
103 GSK Investigational Site Göteborg Sweden SE-413 45
104 GSK Investigational Site Linköping Sweden SE-581 85
105 GSK Investigational Site Lund Sweden SE-221 85
106 GSK Investigational Site Umeå Sweden SE-901 85
107 GSK Investigational Site Uppsala Sweden SE-751 85
108 GSK Investigational Site Cambridge United Kingdom CB3 8RE
109 GSK Investigational Site Clydebank United Kingdom G81 4DY
110 GSK Investigational Site London United Kingdom NW3 2QG
111 GSK Investigational Site London United Kingdom W12 0HS
112 GSK Investigational Site Newcastle upon Tyne United Kingdom NE7 7DN
113 GSK Investigational Site Sheffield United Kingdom S10 2JF

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679224
Other Study ID Numbers:
  • 110094
First Posted:
May 16, 2008
Last Update Posted:
Mar 23, 2017
Last Verified:
Mar 1, 2017
Keywords provided by GlaxoSmithKline
Pulmonary Arterial Hypertesion
observational safety
Additional relevant MeSH terms:
Hypertension, Pulmonary
Ambrisentan

Study Results

No Results Posted as of Mar 23, 2017