The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

NCT ID: NCT00664742

Last Updated: 2011-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

Brief Summary

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This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluvastatin XL® Treatment

80 mg once daily, at bedtime.

Group Type EXPERIMENTAL

Fluvastatin XL®

Intervention Type DRUG

Fluvastatin extended release 80 mg

Interventions

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Fluvastatin XL®

Fluvastatin extended release 80 mg

Intervention Type DRUG

Other Intervention Names

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Lescol XL

Eligibility Criteria

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Inclusion Criteria

* ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
* Triglyceride (TG) \< 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
* Written informed consent for participating in the study

Exclusion Criteria

* Severe renal disease or renal dysfunction
* Chronic liver disease or liver function impairment
* Inflammatory muscle dysfunction or findings of muscle problems
* Severe cardiac failure
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Locations

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Götzepe Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CXUO320BTR03

Identifier Type: -

Identifier Source: org_study_id

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