Effect of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: rosuvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Dilek Ural, MD, Prof, Principal Investigator, Affiliation: Kocaeli University Faculty of Medicine Cardiology Dept
Overall contact:
AstraZeneca Turkey Clinical Study, Information, Phone: 0 212 3172300, Email: zeynep.goztas@astrazeneca.com
Summary
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.
Clinical Details
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)
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome variable is plasma lipid profile (LDL, HDL, total cholesterol, triglyceride)
Secondary outcome: 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 treatmentTo assess the safety profile of rosuvastatin therapy in the study population.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
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
Locations and Contacts
AstraZeneca Turkey Clinical Study, Information, Phone: 0 212 3172300, Email: zeynep.goztas@astrazeneca.com
Research Site, Izmir, Turkey; Recruiting
Research Site, Trabzon, Turkey; Recruiting
Research site, Ankara, Besevler, Turkey; Recruiting
Research site, Kayseri, Erciyes, Turkey; Recruiting
Research site, Instanbul, Haseki, Turkey; Recruiting
Research site, Kocaeli, Umuttepe, Turkey; Recruiting
Additional Information
Starting date: December 2008
Ending date: November 2009
Last updated: August 6, 2009
|
