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An Observational Study For Ambrisentan (VOLT)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679224
First received: May 14, 2008
Last updated: March 21, 2017
Last verified: March 2017
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | May 14, 2008 | |||
| Last Updated Date | March 21, 2017 | |||
| Start Date ICMJE | June 2008 | |||
| Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
safety monitoring | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00679224 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
safety monitoring | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | An Observational Study For Ambrisentan | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | 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 ICMJE | Hypertension, Pulmonary | |||
| Intervention ICMJE | 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 | |||
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* 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 ICMJE | Completed | |||
| Enrollment ICMJE | 800 | |||
| Completion Date | July 2013 | |||
| Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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 ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00679224 | |||
| Other Study ID Numbers ICMJE | 110094 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | GlaxoSmithKline | |||
| Study Sponsor ICMJE | GlaxoSmithKline | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | GlaxoSmithKline | |||
| Verification Date | March 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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