An Observational Study For Ambrisentan (VOLT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00679224 |
Recruitment Status
:
Completed
First Posted
: May 16, 2008
Last Update Posted
: March 23, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | ||||
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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 |
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 |
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 |
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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 |
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Study Groups/Cohorts | ambrisentan prescribed subjects
ambrisentan prescribed subjects
Intervention: Drug: ambrisentan |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
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 |
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Ages | Child, Adult, Senior | |||
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 |
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PRS Account | GlaxoSmithKline | |||
Verification Date | March 2017 |