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An Observational Study For Ambrisentan (VOLT)

This study is currently recruiting participants.
Verified August 2012 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679224
First received: May 14, 2008
Last updated: October 25, 2012
Last verified: August 2012
History of Changes
  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: Time Perspective: Prospective
Official Title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • safety monitoring [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety monitoring [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: June 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679224

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 109 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679224     History of Changes
Other Study ID Numbers: 110094
Study First Received: May 14, 2008
Last Updated: October 25, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Pulmonary Arterial Hypertesion
observational safety

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013