Official Title: “Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia”

The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 5mg oral
• Drug: Pravastatin
  • 40mg oral
• Drug: Atorvastatin
  • 10mg oral

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Rosuvastatin and Pravastatin
• Active Comparator: 2
  • Rosuvastatin and Atorvastatin

Primary Measures

• The primary objective of this study is to compare the variation (as a percentage of baseline values) of the LDL-C level after treatment with: Rosuvastatin versus Pravastatin and Rosuvastatin versus Atorvastatin.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Compare the variation (as a percentage of baseline values) of total cholesterol, HDL-C and triglyceride levels, of ApoB/ApoA1 ratio, of CRP and phospholipase A2 levels after treatment with: Rosuvastatin vs. Pravastatin and Rosuvastatin vs. Atorvastatin
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks)

Exclusion Criteria:

• homozygous or heterozygous familial hypercholesterolaemia
• hypertriglyceridaemia (TG ≥ 4 g/l)
• subjects at high cardiovascular risk according to the AFSSAPS 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD risk > 20%)
• history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor (particularly a history of myopathy)
• concomitant use of any drugs not authorized during the study
• active liver disease with elevation of serum transaminases (ASAT, ALAT) more than twice the upper limit of normal
• CPK more than 3 times the upper limit of normal
• moderate or severe renal failure (creatinine clearance < 6 ml/min)
• poorly controlled hypothyroidism; poorly controlled hypertension (DBP > 95 mm Hg and/or SBP > 180 mm Hg)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Michel Farnier, MD Principal Investigator Le Point Medical - Rond Point du Jour  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631189

Study ID Number: D3560L00068

ClinicalTrials.gov Identifier: NCT00631189

Health Authority: France: Afssaps - French Health Products Safety Agency