Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

NCT ID: NCT00815659

Last Updated: 2011-08-31

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-03-31

Brief Summary

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The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

Detailed Description

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Conditions

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Metabolic Syndrome

Keywords

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plasma lipid profile 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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Rosuvastatin

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Interventions

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rosuvastatin

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Intervention Type DRUG

Other Intervention Names

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CRESTOR

Eligibility Criteria

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Inclusion Criteria

* metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
* LDL-Cholesterol \> 130mg/dl
* HDL-Cholesterol \< 40mg/dl in males and \<50mg/dl in females
* Triglycerides \< 400 mg/dl

Exclusion Criteria

* With a concomitant coronary disease
* Currently under statin therapy or previously treated with statins within the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dilek Ural, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University Faculty of Medicine Cardiology Dept

Locations

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Research site

Ankara, Besevler, Turkey (Türkiye)

Site Status

Research site

Kayseri, Erciyes, Turkey (Türkiye)

Site Status

Research site

Istanbul, Haseki, Turkey (Türkiye)

Site Status

Research site

Kocaeli, Umuttepe, Turkey (Türkiye)

Site Status

Research Site

Izmir, , Turkey (Türkiye)

Site Status

Research Site

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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D3560L00079

Identifier Type: -

Identifier Source: org_study_id