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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00631189
• Date of registration: 28/02/2008
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: 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 CAP-Chol
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 668
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00631189
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Michel Farnier, MD
• Affiliation: Le Point Medical - Rond Point du Jour

Key inclusion & exclusion 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 < 6 ml/min)

- poorly controlled hypothyroidism; poorly controlled hypertension (DBP > 95 mm Hg
and/or SBP > 180 mm Hg)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type IIa and IIb Hypercholesterolaemia

Intervention(s)

Drug: Pravastatin

Drug: Rosuvastatin

Drug: Atorvastatin

Primary Outcome(s)

Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks [Time Frame: Change from baseline and after 8 weeks of treatment]

Secondary Outcome(s)

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 [Time Frame: from baseline and after 8 weeks of treatment]

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 [Time Frame: Not done]

Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment [Time Frame: from baseline and after 8 weeks of treatment]

Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients [Time Frame: Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.]

Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment [Time Frame: After 8 weeks of treatment]

Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks [Time Frame: Baseline and after 8 weeks of treatment]

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 [Time Frame: Not done]

Compare the Percentage of Variation of C-reactive Protein (CRP) [Time Frame: baseline and after 8 weeks of treatment]

To Evaluate Clinical and Laboratory Safety [Time Frame: duration of study]

Compare the Percentage of Variation of Phospholipase A2 (PLA2) [Time Frame: from baseline and after 8 weeks of treatment]

Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment [Time Frame: baseline and after 8 weeks of treatment]

Secondary ID(s)

D3560L00068

EudraCT No 2006-006697-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/09/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00631189