Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes (AFORRD)

This study has been completed.
Churchill Hospital
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ClinicalTrials.gov Identifier:
First received: August 30, 2005
Last updated: November 21, 2008
Last verified: November 2008

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
Diabetes, Type 2
Drug: Atorvastatin and Omega-3 fatty acids
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
  • LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:
  • Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)

Secondary Outcome Measures:
  • Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.
  • Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.

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:

  • They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
  • Are not known to have had a cardiovascular event

Exclusion Criteria:

  • They are taking prescribed lipid lowering therapy
  • Have triglycerides > or = 8.0 mmol/L
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00141232

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Sponsors and Collaborators
Churchill Hospital
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00141232     History of Changes
Other Study ID Numbers: A2581114 
Study First Received: August 30, 2005
Last Updated: November 21, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2016