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

This study has been completed.
Sponsor:
Collaborator:
Churchill Hospital
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141232
First received: August 30, 2005
Last updated: November 21, 2008
Last verified: November 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014