Back to resultsEvaluation 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)
Primary Purpose
Type IIa and IIb Hypercholesterolaemia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Rosuvastatin
Pravastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Type IIa and IIb Hypercholesterolaemia focused on measuring dyslipidemia
Eligibility 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)
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Rosuvastatin and Pravastatin
Rosuvastatin and Atorvastatin
Outcomes
Primary Outcome Measures
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
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
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
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
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
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
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
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)
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)
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
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
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
Serious Adverse Event and Adverse Event reported throughout the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631189
Brief 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
Acronym
CAP-Chol
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type IIa and IIb Hypercholesterolaemia
Keywords
dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
668 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Rosuvastatin and Pravastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Rosuvastatin and Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
5mg oral
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
Prevachol
Intervention Description
40mg oral
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
10mg oral
Primary Outcome Measure Information:
Title
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
Description
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
Time Frame
Change from baseline and after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Not done
Title
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
Description
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
Time Frame
Not done
Title
Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment
Description
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
Time Frame
from baseline and after 8 weeks of treatment
Title
Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment
Description
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
Time Frame
After 8 weeks of treatment
Title
Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks
Description
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
Time Frame
Baseline and after 8 weeks of treatment
Title
Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment
Description
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
Time Frame
baseline and after 8 weeks of treatment
Title
Compare the Percentage of Variation of C-reactive Protein (CRP)
Description
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
Time Frame
baseline and after 8 weeks of treatment
Title
Compare the Percentage of Variation of Phospholipase A2 (PLA2)
Description
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
Time Frame
from baseline and after 8 weeks of treatment
Title
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
Description
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
Time Frame
from baseline and after 8 weeks of treatment
Title
Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients
Description
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.
Title
To Evaluate Clinical and Laboratory Safety
Description
Serious Adverse Event and Adverse Event reported throughout the study
Time Frame
duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Farnier, MD
Organizational Affiliation
Le Point Medical - Rond Point du Jour
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aix En Provence
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France
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Allaire
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France
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Amiens
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France
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Ancerville
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France
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Angers
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France
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Annecy
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France
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Anzin
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France
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Arles
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France
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Arthez de Bearn
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France
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Aspach Le Bas
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France
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Aubagne
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France
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Auchel
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France
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Bailleul
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France
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Balma
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France
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Beaucaire
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France
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Belfort
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France
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Bersee
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France
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Bezenet
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France
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Beziers
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France
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Biarritz
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France
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Blois
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France
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Boersch
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France
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Bondues
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France
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Bondy
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France
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Bordeaux
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France
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Brignoud
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France
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Bruay La Buissiere
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France
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Bruges
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France
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Cabanac Et Villagrains
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France
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Cadaujac
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France
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Caen
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France
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Cannes La Bocca
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France
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Carnon
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France
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Caylus
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France
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Cernay
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France
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Cestas
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France
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Champcueil
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France
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Chanceaux Sur Choisille
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France
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Chilly-mazarin
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France
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Clary
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France
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Collioure
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France
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Colombier Fontaine
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France
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Colomiers
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France
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Coulonieix Chamiers
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France
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Crecy La Chapelle
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France
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Crotenay
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France
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Cuise La Motte
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France
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Derval
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France
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Dijon
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France
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Eckbolsheim
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France
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Eckwersheim
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France
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Epernay
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France
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Epinal
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France
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Etang Sur Arroux
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France
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Evreux
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France
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Fargues St Hilaire
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France
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Folembray
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France
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Fos Sur Mer
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France
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Franconville La Garenne
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France
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Gamarde Les Bains
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France
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Gambsheim
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France
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Gradignan
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France
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Grand Couronne
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France
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Grendelbruch
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France
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Guise
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Harnes
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France
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Horbourg Wihr
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France
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Is Sur Tille
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France
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Ivry Sur Seine
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France
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Jarville La Malgrange
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France
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Jeumont
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France
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La Ciotat
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France
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La Courneuve
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France
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La Creche
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France
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La Francheville
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France
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Lacrouzette
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France
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Lamagistere
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France
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Laval
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France
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Le Bouscat
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France
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Le Cannet
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France
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Le Passage
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France
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Leognan
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France
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Les Issambres
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France
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Lille
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France
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Lucheux
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France
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Marcq En Baroeul
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France
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Marseille
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France
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Maslacq
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France
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Mauguio
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France
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Meaux-beauval
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France
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Mennecy
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France
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Mensignac
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France
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Merlimont
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France
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Metz
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France
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Miramont de Guyenne
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France
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Mittersheim
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France
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Monfort En Chalosse
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France
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Monguilhem
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France
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Mont de Marsan
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France
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Montauroux
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France
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Montbeliard
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France
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Monteux
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France
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Montfrin
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France
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Montigny Les Metz
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France
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Montpellier
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France
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Moreuil
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France
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Muespach
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France
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Nancy
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France
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Nogent Sur Marne
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France
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Noyon
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France
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Oberhausbergen
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France
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Orchamps
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France
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Palau Del Vidre
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France
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Paris
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France
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Pauillac
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France
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PAU
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France
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Perigueux
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France
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Pfulgriesheim
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France
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Phalempin
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France
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Pont A Mousson
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France
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Pouilly En Auxois
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France
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Poussan
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France
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Pradines
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France
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Puteaux
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France
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Quimperle
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France
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Rognac
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France
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Rohrwiller
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France
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Roncq
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France
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Roquevaire
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France
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Roubaix
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France
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Saint Etienne
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France
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Saint Martin D'oney
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France
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Saint Medard En Jalles
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France
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Saint Remy
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France
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Salles
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France
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Sarlat La Caneda
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France
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Semur En Auxois
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France
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Serres Castet
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France
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Soissons
Country
France
Facility Name
Research Site
City
Sorcy Saint Martin
Country
France
Facility Name
Research Site
City
St Etienne de Montluc
Country
France
Facility Name
Research Site
City
St Etienne
Country
France
Facility Name
Research Site
City
St Girons
Country
France
Facility Name
Research Site
City
St Jean de Braye
Country
France
Facility Name
Research Site
City
St Leu La Foret
Country
France
Facility Name
Research Site
City
St Morillon
Country
France
Facility Name
Research Site
City
St Remy de Provence
Country
France
Facility Name
Research Site
City
St. Emilion
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Tarare
Country
France
Facility Name
Research Site
City
Targon
Country
France
Facility Name
Research Site
City
Tartas
Country
France
Facility Name
Research Site
City
Tassin La Demi-lune
Country
France
Facility Name
Research Site
City
Thones
Country
France
Facility Name
Research Site
City
Thun St Amand
Country
France
Facility Name
Research Site
City
Toulon
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Trie Sur Baise
Country
France
Facility Name
Research Site
City
Varces Allieres Et Risset
Country
France
Facility Name
Research Site
City
Vatan
Country
France
Facility Name
Research Site
City
Velizy Villacoublay
Country
France
Facility Name
Research Site
City
Vence
Country
France
Facility Name
Research Site
City
Vieux Boucau
Country
France
Facility Name
Research Site
City
Villard Bonnot
Country
France
Facility Name
Research Site
City
Villette D'anthon
Country
France
Facility Name
Research Site
City
Viry Chatillon
Country
France
Facility Name
Research Site
City
Wasselonne
Country
France
Facility Name
Research Site
City
Wattignies
Country
France
Facility Name
Research Site
City
Wattrelos
Country
France
Facility Name
Research Site
City
Yerres
Country
France
Facility Name
Research Site
City
Yffiniac
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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