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)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00631189
First received: February 28, 2008
Last updated: November 25, 2013
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 July 22, 2014