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Sponsored by: |
Mario Negri Institute for Pharmacological Research |
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Information provided by: | Mario Negri Institute for Pharmacological Research |
ClinicalTrials.gov Identifier: | NCT00317707 |
In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.
Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.
The Risk and Prevention study combines an epidemiological and an experimental approach in order to:
Condition | Intervention | Phase |
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Cardiovascular Diseases |
Drug: polyunsaturated fatty acids (n-3 PUFA) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk |
Estimated Enrollment: | 12000 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | February 2011 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Multiple risk factors:
Exclusion Criteria:
Italy | |
Mario Negri Institute for Pharmacological Research | |
Milan, Italy, 20156 |
Study Chair: | Tombesi Massimo, MD | Centro Studi e Ricerca in Medicina Generale, Monza, Italy |
Study Chair: | Tognoni Gianni, MD | Mario Negri Institute for Pharmacological Research, Milan, Italy |
Responsible Party: | Mario Negri Institute for Pharmacological Research ( Tombesi Massimo, MD. Tognoni Gianni MD ) |
Study ID Numbers: | R&P |
Study First Received: | April 21, 2006 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00317707 History of Changes |
Health Authority: | Italy: Ministry of Health |
cardiovascular risk cardiovascular diseases cardiovascular prevention polyunsaturated fatty acids |
diabetes hypertension hypercholesterolemia obesity |
Obesity Diabetes Mellitus Hypercholesterolemia Hypertension |
Cardiovascular Diseases |