Efficacy Evaluation of Rosuvastatin 5 mg vs Pravastatin 40 mg and Atorvastatin 10 mg in Hypercholesterolaemia Subjects - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00631189

Purpose

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.

Condition	Intervention	Phase
Type IIa and IIb Hypercholesterolaemia	Drug: Rosuvastatin Drug: Pravastatin Drug: Atorvastatin	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Pravastatin Pravastatin sodium Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1150
Study Start Date:	October 2007
Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Active Comparator Rosuvastatin and Pravastatin	Drug: Rosuvastatin 5mg oral Drug: Pravastatin 40mg oral
2: Active Comparator Rosuvastatin and Atorvastatin	Drug: Rosuvastatin 5mg oral Drug: Atorvastatin 10mg oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631189

Show 171 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Michel Farnier, MD

Le Point Medical - Rond Point du Jour

More Information

No publications provided

Responsible Party:	AstraZeneca ( Elisabeth Björk / Medical Science Director )
Study ID Numbers:	D3560L00068, EudraCT No 2006-006697-15
Study First Received:	February 28, 2008
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00631189 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

dyslipidemia

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Pravastatin
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010