Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: Fluvastatin extended release, fenofibrate (Drug); Fixed combination simvastatin/ezetimibe (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharma AG, Study Director, Affiliation: Novartis
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.
Clinical Details
Official title: A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary outcome: Compared at the end of each treatment period:patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl patients reaching target levels of non-HDL-C <130mg/ LDL-C/HDL-C Triglycerides LDL subfractions in a subgroup of patients
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Investigative Centers, Germany
Novartis Pharma AG, Basel, Switzerland
Additional Information
Starting date: August 2006
Last updated: November 7, 2011
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