NCT00679224

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
15 countries

112 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

5.1 years

First QC Date

May 14, 2008

Last Update Submit

March 21, 2017

Conditions

Keywords

Pulmonary Arterial Hypertesionobservational safety

Outcome Measures

Primary Outcomes (1)

  • safety monitoring

Secondary Outcomes (1)

  • safety monitoring

Study Arms (1)

ambrisentan prescribed subjects

ambrisentan prescribed subjects

Drug: ambrisentan

Interventions

ambrisentan

ambrisentan prescribed subjects

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (112)

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Chermside, Queensland, 4032, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

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GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Edmonton, Alberta, T6G 2B7, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R8, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

GSK Investigational Site

London, Ontario, N6A 5W9, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

GSK Investigational Site

Prague, 128 08, Czechia

Location

GSK Investigational Site

Prague, 140 00, Czechia

Location

GSK Investigational Site

Aarhus N, DK-8200, Denmark

Location

GSK Investigational Site

Besançon, 25030, France

Location

GSK Investigational Site

Bordeaux, 33000, France

Location

GSK Investigational Site

Brest, 29200, France

Location

GSK Investigational Site

Bron, 69677, France

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Clamart, 92140, France

Location

GSK Investigational Site

Grenoble, 38043, France

Location

GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Marseille, 13385, France

Location

GSK Investigational Site

Marseille, 13915, France

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Poitiers, 86021, France

Location

GSK Investigational Site

Reims, 51092, France

Location

GSK Investigational Site

Rennes, 35033, France

Location

GSK Investigational Site

Rouen, 76031, France

Location

GSK Investigational Site

Strasbourg, 67098, France

Location

GSK Investigational Site

Toulouse, 31059, France

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GSK Investigational Site

Tours, 37044, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

GSK Investigational Site

Donaueschingen, Baden-Wurttemberg, 78166, Germany

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

GSK Investigational Site

Löwenstein, Baden-Wurttemberg, 74245, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81377, Germany

Location

GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

Location

GSK Investigational Site

Cottbus, Brandenburg, 03048, Germany

Location

GSK Investigational Site

Treuenbrietzen, Brandenburg, 14929, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20246, Germany

Location

GSK Investigational Site

Giessen, Hesse, 35392, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

GSK Investigational Site

Aachen, North Rhine-Westphalia, 52074, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

Location

GSK Investigational Site

Moers, North Rhine-Westphalia, 47441, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42699, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23538, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12559, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12683, Germany

Location

GSK Investigational Site

Alexandroupoli, 68100, Greece

Location

GSK Investigational Site

Athens, 124 62, Greece

Location

GSK Investigational Site

Thessaloniki, 546 36, Greece

Location

GSK Investigational Site

Thessaloniki, 57010, Greece

Location

GSK Investigational Site

Voula / Athens, 166 73, Greece

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

GSK Investigational Site

Rome, Lazio, 00161, Italy

Location

GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Orbassano (TO), Piedmont, 10043, Italy

Location

GSK Investigational Site

Catania, Sicily, 95100, Italy

Location

GSK Investigational Site

Palermo, Sicily, 90127, Italy

Location

GSK Investigational Site

Florence, Tuscany, 50139, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56124, Italy

Location

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Maastricht, 6229 HX, Netherlands

Location

GSK Investigational Site

Nieuwegein, 3435 CM, Netherlands

Location

GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

Location

GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

Location

GSK Investigational Site

Bergen, 5021, Norway

Location

GSK Investigational Site

Oslo, 0027, Norway

Location

GSK Investigational Site

Bratislava, 833 48, Slovakia

Location

GSK Investigational Site

Košice, 040 11, Slovakia

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Ourense, 32005, Spain

Location

GSK Investigational Site

Pontevedra, 36071, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Toledo, 45004, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

GSK Investigational Site

Linköping, SE-581 85, Sweden

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

GSK Investigational Site

Umeå, SE-901 85, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

GSK Investigational Site

Cambridge, CB3 8RE, United Kingdom

Location

GSK Investigational Site

Clydebank, G81 4DY, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, W12 0HS, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations