Back to resultsEfficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fluvastatin extended release, fenofibrate
Fixed combination simvastatin/ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe
Eligibility 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.
Sites / Locations
- Novartis Pharma AG
Outcomes
Primary Outcome Measures
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385658
Brief Title
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluvastatin extended release, fenofibrate
Intervention Type
Drug
Intervention Name(s)
Fixed combination simvastatin/ezetimibe
Primary Outcome Measure Information:
Title
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary Outcome Measure Information:
Title
Compared at the end of each treatment period:
Title
patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
Title
patients reaching target levels of non-HDL-C <130mg/
Title
LDL-C/HDL-C
Title
Triglycerides
Title
LDL subfractions in a subgroup of patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis Pharma AG
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
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