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)

November 25, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Type IIa and IIb Hypercholesterolaemia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

668

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix En Provence, France
    - Research Site
  - Allaire, France
    - Research Site
  - Amiens, France
    - Research Site
  - Ancerville, France
    - Research Site
  - Angers, France
    - Research Site
  - Annecy, France
    - Research Site
  - Anzin, France
    - Research Site
  - Arles, France
    - Research Site
  - Arthez de Bearn, France
    - Research Site
  - Aspach Le Bas, France
    - Research Site
  - Aubagne, France
    - Research Site
  - Auchel, France
    - Research Site
  - Bailleul, France
    - Research Site
  - Balma, France
    - Research Site
  - Beaucaire, France
    - Research Site
  - Belfort, France
    - Research Site
  - Bersee, France
    - Research Site
  - Bezenet, France
    - Research Site
  - Beziers, France
    - Research Site
  - Biarritz, France
    - Research Site
  - Blois, France
    - Research Site
  - Boersch, France
    - Research Site
  - Bondues, France
    - Research Site
  - Bondy, France
    - Research Site
  - Bordeaux, France
    - Research Site
  - Brignoud, France
    - Research Site
  - Bruay La Buissiere, France
    - Research Site
  - Bruges, France
    - Research Site
  - Cabanac Et Villagrains, France
    - Research Site
  - Cadaujac, France
    - Research Site
  - Caen, France
    - Research Site
  - Cannes La Bocca, France
    - Research Site
  - Carnon, France
    - Research Site
  - Caylus, France
    - Research Site
  - Cernay, France
    - Research Site
  - Cestas, France
    - Research Site
  - Champcueil, France
    - Research Site
  - Chanceaux Sur Choisille, France
    - Research Site
  - Chilly-mazarin, France
    - Research Site
  - Clary, France
    - Research Site
  - Collioure, France
    - Research Site
  - Colombier Fontaine, France
    - Research Site
  - Colomiers, France
    - Research Site
  - Coulonieix Chamiers, France
    - Research Site
  - Crecy La Chapelle, France
    - Research Site
  - Crotenay, France
    - Research Site
  - Cuise La Motte, France
    - Research Site
  - Derval, France
    - Research Site
  - Dijon, France
    - Research Site
  - Eckbolsheim, France
    - Research Site
  - Eckwersheim, France
    - Research Site
  - Epernay, France
    - Research Site
  - Epinal, France
    - Research Site
  - Etang Sur Arroux, France
    - Research Site
  - Evreux, France
    - Research Site
  - Fargues St Hilaire, France
    - Research Site
  - Folembray, France
    - Research Site
  - Fos Sur Mer, France
    - Research Site
  - Franconville La Garenne, France
    - Research Site
  - Gamarde Les Bains, France
    - Research Site
  - Gambsheim, France
    - Research Site
  - Gradignan, France
    - Research Site
  - Grand Couronne, France
    - Research Site
  - Grendelbruch, France
    - Research Site
  - Guise, France
    - Research Site
  - Harnes, France
    - Research Site
  - Horbourg Wihr, France
    - Research Site
  - Is Sur Tille, France
    - Research Site
  - Ivry Sur Seine, France
    - Research Site
  - Jarville La Malgrange, France
    - Research Site
  - Jeumont, France
    - Research Site
  - La Ciotat, France
    - Research Site
  - La Courneuve, France
    - Research Site
  - La Creche, France
    - Research Site
  - La Francheville, France
    - Research Site
  - Lacrouzette, France
    - Research Site
  - Lamagistere, France
    - Research Site
  - Laval, France
    - Research Site
  - Le Bouscat, France
    - Research Site
  - Le Cannet, France
    - Research Site
  - Le Passage, France
    - Research Site
  - Leognan, France
    - Research Site
  - Les Issambres, France
    - Research Site
  - Lille, France
    - Research Site
  - Lucheux, France
    - Research Site
  - Marcq En Baroeul, France
    - Research Site
  - Marseille, France
    - Research Site
  - Maslacq, France
    - Research Site
  - Mauguio, France
    - Research Site
  - Meaux-beauval, France
    - Research Site
  - Mennecy, France
    - Research Site
  - Mensignac, France
    - Research Site
  - Merlimont, France
    - Research Site
  - Metz, France
    - Research Site
  - Miramont de Guyenne, France
    - Research Site
  - Mittersheim, France
    - Research Site
  - Monfort En Chalosse, France
    - Research Site
  - Monguilhem, France
    - Research Site
  - Mont de Marsan, France
    - Research Site
  - Montauroux, France
    - Research Site
  - Montbeliard, France
    - Research Site
  - Monteux, France
    - Research Site
  - Montfrin, France
    - Research Site
  - Montigny Les Metz, France
    - Research Site
  - Montpellier, France
    - Research Site
  - Moreuil, France
    - Research Site
  - Muespach, France
    - Research Site
  - Nancy, France
    - Research Site
  - Nogent Sur Marne, France
    - Research Site
  - Noyon, France
    - Research Site
  - Oberhausbergen, France
    - Research Site
  - Orchamps, France
    - Research Site
  - PAU, France
    - Research Site
  - Palau Del Vidre, France
    - Research Site
  - Paris, France
    - Research Site
  - Pauillac, France
    - Research Site
  - Perigueux, France
    - Research Site
  - Pfulgriesheim, France
    - Research Site
  - Phalempin, France
    - Research Site
  - Pont A Mousson, France
    - Research Site
  - Pouilly En Auxois, France
    - Research Site
  - Poussan, France
    - Research Site
  - Pradines, France
    - Research Site
  - Puteaux, France
    - Research Site
  - Quimperle, France
    - Research Site
  - Rognac, France
    - Research Site
  - Rohrwiller, France
    - Research Site
  - Roncq, France
    - Research Site
  - Roquevaire, France
    - Research Site
  - Roubaix, France
    - Research Site
  - Saint Etienne, France
    - Research Site
  - Saint Martin D'oney, France
    - Research Site
  - Saint Medard En Jalles, France
    - Research Site
  - Saint Remy, France
    - Research Site
  - Salles, France
    - Research Site
  - Sarlat La Caneda, France
    - Research Site
  - Semur En Auxois, France
    - Research Site
  - Serres Castet, France
    - Research Site
  - Soissons, France
    - Research Site
  - Sorcy Saint Martin, France
    - Research Site
  - St Etienne, France
    - Research Site
  - St Etienne de Montluc, France
    - Research Site
  - St Girons, France
    - Research Site
  - St Jean de Braye, France
    - Research Site
  - St Leu La Foret, France
    - Research Site
  - St Morillon, France
    - Research Site
  - St Remy de Provence, France
    - Research Site
  - St. Emilion, France
    - Research Site
  - Strasbourg, France
    - Research Site
  - Tarare, France
    - Research Site
  - Targon, France
    - Research Site
  - Tartas, France
    - Research Site
  - Tassin La Demi-lune, France
    - Research Site
  - Thones, France
    - Research Site
  - Thun St Amand, France
    - Research Site
  - Toulon, France
    - Research Site
  - Toulouse, France
    - Research Site
  - Trie Sur Baise, France
    - Research Site
  - Varces Allieres Et Risset, France
    - Research Site
  - Vatan, France
    - Research Site
  - Velizy Villacoublay, France
    - Research Site
  - Vence, France
    - Research Site
  - Vieux Boucau, France
    - Research Site
  - Villard Bonnot, France
    - Research Site
  - Villette D'anthon, France
    - Research Site
  - Viry Chatillon, France
    - Research Site
  - Wasselonne, France
    - Research Site
  - Wattignies, France
    - Research Site
  - Wattrelos, France
    - Research Site
  - Yerres, France
    - Research Site
  - Yffiniac, France
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 Rosuvastatin and Pravastatin	Drug: Rosuvastatin 5mg oral Other Names: Crestor Drug: Pravastatin 40mg oral Other Names: Prevachol
Active Comparator: 2 Rosuvastatin and Atorvastatin	Drug: Rosuvastatin 5mg oral Other Names: Crestor Drug: Atorvastatin 10mg oral Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks Time Frame: Change from baseline and after 8 weeks of treatment	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	Change from baseline and after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Not done
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	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	Not done
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	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	from baseline and after 8 weeks of treatment
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	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	After 8 weeks of treatment
Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks Time Frame: Baseline and after 8 weeks of treatment	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	Baseline and after 8 weeks of treatment
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	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	baseline and after 8 weeks of treatment
Compare the Percentage of Variation of C-reactive Protein (CRP) Time Frame: baseline and after 8 weeks of treatment	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	baseline and after 8 weeks of treatment
Compare the Percentage of Variation of Phospholipase A2 (PLA2) Time Frame: from baseline and after 8 weeks of treatment	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	from baseline and after 8 weeks of treatment
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	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	from baseline and after 8 weeks of treatment
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 Time Frame: duration of study	Serious Adverse Event and Adverse Event reported throughout the study	duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Michel Farnier, MD, Le Point Medical - Rond Point du Jour

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

dyslipidemia

Additional Relevant MeSH Terms

Other Study ID Numbers

D3560L00068
EudraCT No 2006-006697-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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)

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 Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Type IIa and IIb Hypercholesterolaemia

Clinical Trials on Rosuvastatin

Search Similar Trials

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