Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes (AFORRD)
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|ClinicalTrials.gov Identifier: NCT00141232|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 24, 2008
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 or disease||Intervention/treatment||Phase|
|Diabetes, Type 2||Drug: Atorvastatin and Omega-3 fatty acids||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||810 participants|
|Intervention Model:||Factorial Assignment|
|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|
|Study Start Date :||November 2004|
|Study Completion Date :||July 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141232
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|