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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00689377 |
Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.
Condition |
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Peripheral Arterial Disease (PAD) Moderate Risk for Cardiovascular Disease (CVD) |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus |
Estimated Enrollment: | 9000 |
Study Start Date: | May 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus
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Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Raffaele Sabia | AstraZeneca S.p.A. |
Study Chair: | Mario Mangrella | AstraZeneca S.p.A |
Study Chair: | Claudio Cimminiello | Unit of Medicine, Vimercate Hospital - Vimercate (MI) - Italy |
Study Chair: | Claudio Borghi | Internal Medicine Dept., di Medicina Interna, Policlinico Universitario Sant'Orsola-Malpighi, Bologna, Italy |
Responsible Party: | AstraZeneca S.p.A ( Raffaele Sabia, MD, VP R&D, AstraZeneca S.p.A ) |
Study ID Numbers: | NIS-CEU-DUM-2006/1 |
Study First Received: | May 29, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00689377 |
Health Authority: | France: Direction Générale de la Santé; Greece: National Organization of Medicines; Italy: Ethics Committee; Netherlands: Medical Ethics Review Committee (METC); Switzerland: Ethikkommission |
Peripheral Arterial Disease (PAD) Cardiovascular Disease (CVD) Atherosclerotic cardiovascular disease Atherosclerosis Primary CVD prevention |
Atherosclerosis Peripheral Vascular Diseases Diabetes Mellitus Vascular Diseases |
Cardiovascular Diseases |