Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes (AFORRD)
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?
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
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|
- 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)
- 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.
|Study Start Date:||November 2004|
|Study Completion Date:||July 2006|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|