An Observational Study For Ambrisentan - Full Text View

An Observational Study For Ambrisentan (VOLT)

This study is not yet open for participant recruitment.

Verified by GlaxoSmithKline, September 2009

First Received: May 14, 2008 Last Updated: September 3, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00679224

Purpose

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

Condition	Intervention
Pulmonary Arterial Hypertension	Drug: ambrisentan

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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 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:	Non-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

Show 76 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110094
Study First Received:	May 14, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00679224 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:

observational safety

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009