An Observational Study For Ambrisentan (VOLT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679224
First received: May 14, 2008
Last updated: November 7, 2013
Last verified: November 2013
  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:


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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679224

  Show 113 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: November 7, 2013
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 September 16, 2014