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)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type IIa and IIb Hypercholesterolaemia

Treatments: Drug: Atorvastatin; Drug: Pravastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631189

EudraCT No 2006-006697-15

D3560L00068

Details and patient eligibility

About

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.

Enrollment: 668 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

668 participants in 2 patient groups

1

Active Comparator group

Description:

Rosuvastatin and Pravastatin

Treatment:

Drug: Rosuvastatin

Drug: Pravastatin

2

Active Comparator group

Description:

Rosuvastatin and Atorvastatin

Treatment:

Drug: Rosuvastatin

Drug: Atorvastatin