Phase 4
Completed N=668
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
Type IIa and IIb Hypercholesterolaemia
Source: ClinicalTrials.gov NCT00631189 ↗
Enrolled (actual)
668
Serious AEs
1.2%
Results posted
Sep 2010
Primary outcomePrimary: Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks — -39.4; -30.3; -37.6 percentage of LDL-C decrease
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks |
-39.4; -30.3; -37.6 | — |
| SECONDARY To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients |
— | — |
| SECONDARY To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients |
— | — |
| SECONDARY Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment |
-28.6; -20.4; -25.2 | — |
| SECONDARY Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment |
4.4; 7.9; 11.3 | — |
| SECONDARY Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks |
-19.2; -6.1; -8.7 | — |
| SECONDARY Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment |
-30.9; -26; -31.9 | — |
| SECONDARY Compare the Percentage of Variation of C-reactive Protein (CRP) |
37.3; 33.1; 15.2 | — |
| SECONDARY Compare the Percentage of Variation of Phospholipase A2 (PLA2) |
5.6; 13; 2.9 | — |
| SECONDARY Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients |
42; 22; 38 | — |
| SECONDARY Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients |
— | — |
| SECONDARY To Evaluate Clinical and Laboratory Safety |
8; 9; 8; 5 | — |
Eligibility Criteria
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 95 mm Hg and/or SBP > 180 mm Hg)
Data sourced from ClinicalTrials.gov (NCT00631189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.