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

This study has been completed.

Study NCT00664742 Information provided by Novartis

First Received on April 21, 2008. Last Updated on April 19, 2011 History of Changes

Results First Received: January 5, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metabolic Syndrome
Intervention:	Drug: Fluvastatin XL®

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
614 participants enrolled. 607 participants treated.

Reporting Groups

	Description
Fluvastatin XL® Treatment	80 mg once daily, at bedtime.

Participant Flow: Overall Study

	Fluvastatin XL® Treatment
STARTED	607
COMPLETED	481
NOT COMPLETED	126
Withdrawn due to adverse events	3
Withdrawal by Subject	31
Lost to Follow-up	92

Baseline Characteristics

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Reporting Groups

	Description
Fluvastatin XL® Treatment	80 mg once daily, at bedtime.

Baseline Measures

	Fluvastatin XL® Treatment
Number of Participants [units: participants]	607
Age [units: years] Mean ± Standard Deviation	54 ± 10
Gender, Customized [units: participants]
Female	421
Male	183
Gender not recorded	3

Outcome Measures

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1. Primary:

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 [ Time Frame: Baseline,6 weeks ]

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2. Secondary:

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 [ Time Frame: Baseline, 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Medical Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00664742 History of Changes
Other Study ID Numbers:	CXUO320BTR03
Study First Received:	April 21, 2008
Results First Received:	January 5, 2011
Last Updated:	April 19, 2011
Health Authority:	Turkey: Ministry of Health