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 (AFORRD)

NCT00141232 Phase 4 COMPLETED

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?

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	810
Start date	2004-11
Completion	2006-07

Conditions

• Diabetes, Type 2

Interventions

• Atorvastatin and Omega-3 fatty acids

Primary outcomes

• 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)

Countries

United Kingdom