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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00679224 |
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Condition | Intervention |
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Pulmonary Arterial Hypertension |
Drug: ambrisentan |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT) |
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 |
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ambrisentan prescribed subjects
ambrisentan prescribed subjects
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Drug: ambrisentan
ambrisentan
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The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
subjects who have been prescribed ambrisentan for a medically appropriate use. (See approved product label e.g.
Summary of Product Characteristics. )
subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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 |
observational safety |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Cardiovascular Diseases Hypertension |