COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

Metabolic Syndrome Clinical Trial

Official title:

A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654485
• Other study ID #: 4522IL/0069
• Secondary ID: D3560C00069
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: March 13, 2009
• Start date: May 2002
• Est. completion date: February 2005

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencySlovakia: State Institute for Drug ControlUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of 3 or more coronary heart disease risk factors as defined by the protocol.

• Fasting low density lipoprotein cholesterol level of > 130 mg/dL.

• Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

• Not previously taken statins.

Exclusion Criteria:

• The use of lipid lowering drugs or dietary supplements after Visit 1

• Active arterial disease eg Unstable angina, or recent arterial surgery

• Blood lipid levels above the limits defined in the protocol

• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.		At 6 & 12 weeks
Secondary	Modification of other lipids and lipoproteins		At 6 & 12 weeks
Secondary	Modification of insulin resistance, inflammatory markers & glucose metabolism		At 6 & 12 weeks
Secondary	Safety: adverse events & abnormal laboratory markers		At 6 & 12 weeks