Effect of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00815659

Purpose

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

Condition	Intervention	Phase
Metabolic Syndrome	Drug: rosuvastatin	Phase IV

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin Rosuvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary outcome variable is plasma lipid profile (LDL, HDL, total cholesterol, triglyceride) [ Time Frame: weeks -2, 0, 6, 9, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate efficacy of rosuvastatin therapy on the following parameters: a. Small dense LDL and subfractions of HDL b. Inflammation markers (IL 1, 8, 10, TNF, hsCRP) c. Percentage of patients reaching treatment goals at the end of the treatment [ Time Frame: weeks 0, 6, 12 ] [ Designated as safety issue: No ]
To assess the safety profile of rosuvastatin therapy in the study population. [ Time Frame: Recruitment period & follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rosuvastatin: Experimental medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.	Drug: rosuvastatin medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

metabolic syndrome (according to NCEP 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815659

Contacts

Contact: AstraZeneca Turkey Clinical Study, Information

0 212 3172300

zeynep.goztas@astrazeneca.com

Locations

Turkey, Besevler
Research site	Recruiting
Ankara, Besevler, Turkey
Turkey, Erciyes
Research site	Recruiting
Kayseri, Erciyes, Turkey
Turkey, Haseki
Research site	Recruiting
Instanbul, Haseki, Turkey
Turkey, Kartal
Research site	Active, not recruiting
Instanbul, Kartal, Turkey
Turkey, Umuttepe
Research site	Recruiting
Kocaeli, Umuttepe, Turkey

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Dilek Ural, MD, Prof

Kocaeli University Faculty of Medicine Cardiology Dept

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mujgan Ates - Medical Director )
Study ID Numbers:	D3560L00079
Study First Received:	December 29, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00815659
Health Authority:	Turkey: Ministry of Health

Keywords provided by AstraZeneca:

plasma lipid profile
metabolic syndrome

Study placed in the following topic categories:

Rosuvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Syndrome
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009