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Trial record 7 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385658
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Fluvastatin extended release, fenofibrate Drug: Fixed combination simvastatin/ezetimibe Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.

Secondary Outcome Measures :
  1. Compared at the end of each treatment period:
  2. patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
  3. patients reaching target levels of non-HDL-C <130mg/
  4. LDL-C/HDL-C
  5. Triglycerides
  6. LDL subfractions in a subgroup of patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00385658

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Investigative Centers, Germany
Novartis Pharma AG
Basel, Switzerland
Sponsors and Collaborators
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Study Director: Novartis Pharma AG Novartis

Additional Information:
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Responsible Party: Novartis Identifier: NCT00385658     History of Changes
Other Study ID Numbers: CXUO320BDE35
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Novartis:
metabolic syndrome

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors