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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

Page last updated: August 23, 2015

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