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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Fluvastatin XL®

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome,dyslipidemia,fluvastatin extended release

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Other protocol defined inclusion exclusion criteria may apply

Sites / Locations

Götzepe Education and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluvastatin XL® Treatment

Arm Description

80 mg once daily, at bedtime.

Outcomes

Primary Outcome Measures

Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6

Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

Secondary Outcome Measures

Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels

The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.

Full Information

NCT ID

NCT00664742

First Posted

April 21, 2008

Last Updated

April 19, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00664742

Brief Title

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

Official Title

The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic syndrome,dyslipidemia,fluvastatin extended release

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

614 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluvastatin XL® Treatment

Arm Type

Experimental

Arm Description

80 mg once daily, at bedtime.

Intervention Type

Drug

Intervention Name(s)

Fluvastatin XL®

Other Intervention Name(s)

Lescol XL

Intervention Description

Fluvastatin extended release 80 mg

Primary Outcome Measure Information:

Title

Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6

Description

Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

Time Frame

Baseline,6 weeks

Secondary Outcome Measure Information:

Title

Description

The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.

Time Frame

Baseline, 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Other protocol defined inclusion exclusion criteria may apply

Facility Information:

Facility Name

Götzepe Education and Research Hospital

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

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

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