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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141232
First Posted: September 1, 2005
Last Update Posted: November 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Churchill Hospital
Information provided by:
Pfizer
  Purpose

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
Intervention Model: Factorial Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141232


  Show 59 Study Locations
Sponsors and Collaborators
Pfizer
Churchill Hospital
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00141232     History of Changes
Other Study ID Numbers: A2581114
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: November 24, 2008
Last Verified: November 2008

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