Type IIa and IIb Hypercholesterolaemia Clinical Trial
— CAP-CholOfficial 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
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.
| Status | Completed |
| Enrollment | 668 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Research Site | 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 | Palau Del Vidre | |
| France | Research Site | Paris | |
| France | Research Site | PAU | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change from baseline and after 8 weeks of treatment | No |
| Secondary | 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 | Not done | No |
| Secondary | 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 | Not done | No |
| Secondary | 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 | from baseline and after 8 weeks of treatment | No |
| Secondary | 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 | After 8 weeks of treatment | No |
| Secondary | 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 | Baseline and after 8 weeks of treatment | No |
| Secondary | 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 | baseline and after 8 weeks of treatment | No |
| Secondary | 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 | baseline and after 8 weeks of treatment | No |
| Secondary | 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 | from baseline and after 8 weeks of treatment | No |
| Secondary | 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 | from baseline and after 8 weeks of treatment | No |
| Secondary | 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. | No | |
| Secondary | To Evaluate Clinical and Laboratory Safety | Serious Adverse Event and Adverse Event reported throughout the study | duration of study | No |