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

May 14, 2008
November 7, 2013
June 2008
July 2013   (final data collection date for primary outcome measure)
safety monitoring [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00679224 on ClinicalTrials.gov Archive Site
safety monitoring [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
An Observational Study For Ambrisentan
A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

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

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

subjects who have been prescribed ambrisentan for a medically appropriate use. (See approved product label e.g. Summary of Product Characteristics. )

Hypertension, Pulmonary
Drug: ambrisentan
ambrisentan
ambrisentan prescribed subjects
ambrisentan prescribed subjects
Intervention: Drug: ambrisentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
July 2013
July 2013   (final data collection date for primary outcome measure)

subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   United Kingdom,   Greece,   Italy,   Netherlands,   Norway,   Slovakia,   Spain,   Sweden
 
NCT00679224
110094
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP