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An Observational Study For Ambrisentan (VOLT)

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ClinicalTrials.gov Identifier: NCT00679224
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: ambrisentan

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

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 : June 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ambrisentan
U.S. FDA Resources

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



Primary Outcome Measures :
  1. safety monitoring

Secondary Outcome Measures :
  1. safety monitoring


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. )
Criteria
subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679224


  Show 113 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679224     History of Changes
Other Study ID Numbers: 110094
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by GlaxoSmithKline:
Pulmonary Arterial Hypertesion
observational safety

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Ambrisentan
Antihypertensive Agents