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An Observational Study For Ambrisentan (VOLT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679224
First Posted: May 16, 2008
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

Condition Intervention
Hypertension, Pulmonary Drug: ambrisentan

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • safety monitoring

Secondary Outcome Measures:
  • safety monitoring

Enrollment: 800
Study Start Date: June 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ambrisentan prescribed subjects
ambrisentan prescribed subjects
Drug: ambrisentan
ambrisentan

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
  Contacts and Locations
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
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679224     History of Changes
Other Study ID Numbers: 110094
First Submitted: May 14, 2008
First Posted: May 16, 2008
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