Status:
COMPLETED
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
Lead Sponsor:
Novartis
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.
Eligibility Criteria
Inclusion
- Written informed consent to participate in the study prior to any study procedures.
- Male or female subjects, age between 18-75 years inclusive.
- All women of child bearing potential must have a negative pregnancy test
- Metabolic Syndrome according to the International Diabetes Federation definition:
- Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
- Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
- And one or more of the following criteria:
- Triglycerides ≥ 150 mg/d.l
- Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
- Fasting plasma glucose≥ 100mg/dl.
- Previously diagnosed type 2 diabetes.
Exclusion
- Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
- Type 1 diabetes.
- HbA1c \> 9.5%.
- Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
- History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
- Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00385658
Start Date
August 1 2006
End Date
March 1 2007
Last Update
February 24 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharma AG
Basel, Switzerland