Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes - Full Text View

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

This study has been completed.

First Received on August 30, 2005. Last Updated on November 21, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Diabetes Trials Unit: Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospitals Site, Old Road, Headington, Oxford OX3 7LJ
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141232

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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Statins

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141232

Show 59 Study Locations

Sponsors and Collaborators

Pfizer

Diabetes Trials Unit: Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospitals Site, Old Road, Headington, Oxford OX3 7LJ

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012