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 - 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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks [ Time Frame: Change from baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To compare the percentages of LDL-C level variation. 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

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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
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 ] [ Designated as safety issue: No ]
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 Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment [ Time Frame: from baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To compare the percentage of total cholesterol variation taking baseline value as a reference. 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 ] [ Designated as safety issue: No ]
Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. 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 Variation From Baseline Triglycerides Values and After 8 Weeks [ Time Frame: Baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To compare the percentage of variation from baseline triglycerides values and after 8 weeks. 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 Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment [ Time Frame: baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. 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 Variation of C-reactive Protein (CRP) [ Time Frame: baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. 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 Variation of Phospholipase A2 (PLA2) [ Time Frame: from baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and 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 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 ] [ Designated as safety issue: No ]
To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). 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. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor
Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients [ Designated as safety issue: No ]
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.
To Evaluate Clinical and Laboratory Safety [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Serious Adverse Event and Adverse Event reported throughout the study

Enrollment:	668
Study Start Date:	October 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Rosuvastatin and Pravastatin	Drug: Rosuvastatin 5mg oral Other Name: Crestor Drug: Pravastatin 40mg oral Other Name: Prevachol
Active Comparator: 2 Rosuvastatin and Atorvastatin	Drug: Rosuvastatin 5mg oral Other Name: Crestor Drug: Atorvastatin 10mg oral Other Name: Lipitor

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:	Elisabeth Björk / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00631189 History of Changes
Other Study ID Numbers:	D3560L00068, EudraCT No 2006-006697-15
Study First Received:	February 28, 2008
Results First Received:	March 11, 2010
Last Updated:	June 14, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

dyslipidemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pravastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012