An Observational Study For Ambrisentan (VOLT)

Tracking Information
First Submitted Date	May 14, 2008
First Posted Date	May 16, 2008
Last Update Posted Date	March 23, 2017
Study Start Date	June 2008
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 16, 2009)	safety monitoring
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00679224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 16, 2009)	safety monitoring
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	An Observational Study For Ambrisentan
Official Title	A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)
Brief Summary	The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Detailed Description	The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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. )
Condition	Hypertension, Pulmonary
Intervention	Drug: ambrisentan; ambrisentan
Study Groups/Cohorts	ambrisentan prescribed subjects; ambrisentan prescribed subjects; Intervention: Drug: ambrisentan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 14, 2008)	800
Original Estimated Enrollment	Same as current
Actual Study Completion Date	July 2013
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, United Kingdom
Removed Location Countries
Administrative Information
NCT Number	NCT00679224
Other Study ID Numbers	110094
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	GlaxoSmithKline
Study Sponsor	GlaxoSmithKline
Collaborators	Not Provided
Investigators	Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	March 2017