NCT00141232CompletedPhase 4
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.60 sites in 1 country810 target enrollmentStarted: November 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 810
- Locations
- 60
- Primary Endpoint
- Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
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)
Secondary Outcomes
- 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.
Investigators
Study Sites (60)
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