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Sponsors and Collaborators: |
Pfizer Diabetes Trials Unit: Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospitals Site, Old Road, Headington, Oxford OX3 7LJ |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00141232 |
The AFORRD trial is asking three important questions:
What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?
Condition | Intervention | Phase |
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Diabetes, Type 2 |
Drug: Atorvastatin and Omega-3 fatty acids |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomised, Double Blind Placebo Controlled Trial Evaluating Atorvastatin in Factorial With Omega-3 Fatty Acids Cardiovascular Risk Reduction in Patients With Type 2 Diabetes |
Enrollment: | 810 |
Study Start Date: | November 2004 |
Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A2581114 |
Study First Received: | August 30, 2005 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00141232 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |