CAP-Chol: 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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00631189
• Collaborator: (none)
• Enrollment: 668
• Locations: 171
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type IIa and IIb Hypercholesterolaemia	Drug: Rosuvastatin; Drug: Pravastatin; Drug: Atorvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 668 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks [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

Secondary Outcome Measures

1. 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]

   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

2. 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]

   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

3. Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment [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

4. Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment [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

5. Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks [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

6. Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment [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

7. Compare the Percentage of Variation of C-reactive Protein (CRP) [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

8. Compare the Percentage of Variation of Phospholipase A2 (PLA2) [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

9. 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 [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

10. 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.

11. To Evaluate Clinical and Laboratory Safety [duration of study]

    Serious Adverse Event and Adverse Event reported throughout the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Aix En Provence		France
2	Research Site	Allaire		France
3	Research Site	Amiens		France
4	Research Site	Ancerville		France
5	Research Site	Angers		France
6	Research Site	Annecy		France
7	Research Site	Anzin		France
8	Research Site	Arles		France
9	Research Site	Arthez de Bearn		France
10	Research Site	Aspach Le Bas		France
11	Research Site	Aubagne		France
12	Research Site	Auchel		France
13	Research Site	Bailleul		France
14	Research Site	Balma		France
15	Research Site	Beaucaire		France
16	Research Site	Belfort		France
17	Research Site	Bersee		France
18	Research Site	Bezenet		France
19	Research Site	Beziers		France
20	Research Site	Biarritz		France
21	Research Site	Blois		France
22	Research Site	Boersch		France
23	Research Site	Bondues		France
24	Research Site	Bondy		France
25	Research Site	Bordeaux		France
26	Research Site	Brignoud		France
27	Research Site	Bruay La Buissiere		France
28	Research Site	Bruges		France
29	Research Site	Cabanac Et Villagrains		France
30	Research Site	Cadaujac		France
31	Research Site	Caen		France
32	Research Site	Cannes La Bocca		France
33	Research Site	Carnon		France
34	Research Site	Caylus		France
35	Research Site	Cernay		France
36	Research Site	Cestas		France
37	Research Site	Champcueil		France
38	Research Site	Chanceaux Sur Choisille		France
39	Research Site	Chilly-mazarin		France
40	Research Site	Clary		France
41	Research Site	Collioure		France
42	Research Site	Colombier Fontaine		France
43	Research Site	Colomiers		France
44	Research Site	Coulonieix Chamiers		France
45	Research Site	Crecy La Chapelle		France
46	Research Site	Crotenay		France
47	Research Site	Cuise La Motte		France
48	Research Site	Derval		France
49	Research Site	Dijon		France
50	Research Site	Eckbolsheim		France
51	Research Site	Eckwersheim		France
52	Research Site	Epernay		France
53	Research Site	Epinal		France
54	Research Site	Etang Sur Arroux		France
55	Research Site	Evreux		France
56	Research Site	Fargues St Hilaire		France
57	Research Site	Folembray		France
58	Research Site	Fos Sur Mer		France
59	Research Site	Franconville La Garenne		France
60	Research Site	Gamarde Les Bains		France
61	Research Site	Gambsheim		France
62	Research Site	Gradignan		France
63	Research Site	Grand Couronne		France
64	Research Site	Grendelbruch		France
65	Research Site	Guise		France
66	Research Site	Harnes		France
67	Research Site	Horbourg Wihr		France
68	Research Site	Is Sur Tille		France
69	Research Site	Ivry Sur Seine		France
70	Research Site	Jarville La Malgrange		France
71	Research Site	Jeumont		France
72	Research Site	La Ciotat		France
73	Research Site	La Courneuve		France
74	Research Site	La Creche		France
75	Research Site	La Francheville		France
76	Research Site	Lacrouzette		France
77	Research Site	Lamagistere		France
78	Research Site	Laval		France
79	Research Site	Le Bouscat		France
80	Research Site	Le Cannet		France
81	Research Site	Le Passage		France
82	Research Site	Leognan		France
83	Research Site	Les Issambres		France
84	Research Site	Lille		France
85	Research Site	Lucheux		France
86	Research Site	Marcq En Baroeul		France
87	Research Site	Marseille		France
88	Research Site	Maslacq		France
89	Research Site	Mauguio		France
90	Research Site	Meaux-beauval		France
91	Research Site	Mennecy		France
92	Research Site	Mensignac		France
93	Research Site	Merlimont		France
94	Research Site	Metz		France
95	Research Site	Miramont de Guyenne		France
96	Research Site	Mittersheim		France
97	Research Site	Monfort En Chalosse		France
98	Research Site	Monguilhem		France
99	Research Site	Mont de Marsan		France
100	Research Site	Montauroux		France
101	Research Site	Montbeliard		France
102	Research Site	Monteux		France
103	Research Site	Montfrin		France
104	Research Site	Montigny Les Metz		France
105	Research Site	Montpellier		France
106	Research Site	Moreuil		France
107	Research Site	Muespach		France
108	Research Site	Nancy		France
109	Research Site	Nogent Sur Marne		France
110	Research Site	Noyon		France
111	Research Site	Oberhausbergen		France
112	Research Site	Orchamps		France
113	Research Site	Palau Del Vidre		France
114	Research Site	Paris		France
115	Research Site	Pauillac		France
116	Research Site	PAU		France
117	Research Site	Perigueux		France
118	Research Site	Pfulgriesheim		France
119	Research Site	Phalempin		France
120	Research Site	Pont A Mousson		France
121	Research Site	Pouilly En Auxois		France
122	Research Site	Poussan		France
123	Research Site	Pradines		France
124	Research Site	Puteaux		France
125	Research Site	Quimperle		France
126	Research Site	Rognac		France
127	Research Site	Rohrwiller		France
128	Research Site	Roncq		France
129	Research Site	Roquevaire		France
130	Research Site	Roubaix		France
131	Research Site	Saint Etienne		France
132	Research Site	Saint Martin D'oney		France
133	Research Site	Saint Medard En Jalles		France
134	Research Site	Saint Remy		France
135	Research Site	Salles		France
136	Research Site	Sarlat La Caneda		France
137	Research Site	Semur En Auxois		France
138	Research Site	Serres Castet		France
139	Research Site	Soissons		France
140	Research Site	Sorcy Saint Martin		France
141	Research Site	St Etienne de Montluc		France
142	Research Site	St Etienne		France
143	Research Site	St Girons		France
144	Research Site	St Jean de Braye		France
145	Research Site	St Leu La Foret		France
146	Research Site	St Morillon		France
147	Research Site	St Remy de Provence		France
148	Research Site	St. Emilion		France
149	Research Site	Strasbourg		France
150	Research Site	Tarare		France
151	Research Site	Targon		France
152	Research Site	Tartas		France
153	Research Site	Tassin La Demi-lune		France
154	Research Site	Thones		France
155	Research Site	Thun St Amand		France
156	Research Site	Toulon		France
157	Research Site	Toulouse		France
158	Research Site	Trie Sur Baise		France
159	Research Site	Varces Allieres Et Risset		France
160	Research Site	Vatan		France
161	Research Site	Velizy Villacoublay		France
162	Research Site	Vence		France
163	Research Site	Vieux Boucau		France
164	Research Site	Villard Bonnot		France
165	Research Site	Villette D'anthon		France
166	Research Site	Viry Chatillon		France
167	Research Site	Wasselonne		France
168	Research Site	Wattignies		France
169	Research Site	Wattrelos		France
170	Research Site	Yerres		France
171	Research Site	Yffiniac		France

Sponsors and Collaborators

• AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00631189
• Other Study ID Numbers: D3560L00068; EudraCT No 2006-006697-15
• First Posted: Mar 7, 2008
• Last Update Posted: Nov 26, 2013
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: dyslipidemia
• Additional relevant MeSH terms: Hypercholesterolemia; Atorvastatin; Rosuvastatin Calcium; Pravastatin

Study Results

Participant Flow

Recruitment Details	Patients were recruited by general practitioner. First patient included: 12 October 2007 Last patient terminated the study: 04 October 2008
Pre-assignment Detail	This French multicentre, randomized double-blind study was conducted on three parallel arms. The 14-week study comprised 3 visits: a screening visit (week 0, V1), a randomization and treatment allocation visit (week 6, V2) and an evaluation visit (week 14, V3). Patients were randomized at V2 and were treated for a period of 8 weeks.

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Period Title: Initial Phase
STARTED	668	0	0	0
COMPLETED	317	0	0	0
NOT COMPLETED	351	0	0	0
Period Title: Initial Phase
STARTED	0	104	103	110
COMPLETED	0	97	92	103
NOT COMPLETED	0	7	11	7

Baseline Characteristics

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin	Total
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg	Total of all reporting groups
Overall Participants	0	104	103	110	317
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.31 (10.59)	57.23 (10.8)	57.04 (9.32)	57.18 (9.95)
Gender (Number) [Number]
Female	49 Infinity	55 52.9%	46 44.7%	150 136.4%
Male	55 Infinity	48 46.2%	64 62.1%	167 151.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percentage of LDL-C decrease]	-39.4 (13.77)	-30.3 (15.43)	-37.6 (17.96)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percentage of total cholesterol decrease]	-28.6 (11.0)	-20.4 (11.7)	-25.2 (14.0)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percentage of HDL-C increase]	4.4 (14.3)	7.9 (19.2)	11.3 (20.6)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percentage of triglycerides decrease]	-19.2 (25)	-6.1 (31.6)	-8.7 (37)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percent. Apolipoprotein B/A1 decrease]	-30.9 (14.7)	-26 (13.5)	-31.9 (17)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Mean (Standard Deviation) [percent of variation of C-reactive prot.]	37.3 (187.4)	33.1 (184.2)	15.2 (104.9)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	84	78	83
Mean (Standard Deviation) [percent of variation of phospholipase A2]	5.6 (46.4)	13 (73.6)	2.9 (24.2)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	0	97	91	103
Number [Participants]	42 Infinity	22 21.2%	38 36.9%

11. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	To Evaluate Clinical and Laboratory Safety
Description	Serious Adverse Event and Adverse Event reported throughout the study
Time Frame	duration of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)	Atorvastatin 10 mg	Pravastatin 40 mg	Rosuvastatin 5 mg
Measure Participants	317	97	92	103
Number [Adverse Events]	8	9	8	5

Adverse Events

Arm/Group Title	Initial Phase		Atorvastatin		Pravastatin		Rosuvastatin
Arm/Group Description	Initial phase (between V1 and V2)		Atorvastatin 10 mg		Pravastatin 40 mg		Rosuvastatin 5 mg
All Cause Mortality
	Initial Phase		Atorvastatin		Pravastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Initial Phase		Atorvastatin		Pravastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/317 (0.6%)		4/97 (4.1%)		1/92 (1.1%)		0/103 (0%)
Gastrointestinal disorders
VIiolent abdominal pain	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Musculoskeletal and connective tissue disorders
Coxarthrosisaggravation	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Worsening of gonalgia	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Nervous system disorders
Carotid thrombosis	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Left Lumbar Cruralgia	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Morton syndrome	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Reproductive system and breast disorders
Benign prostatic nodular hyperplasia	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
Other (Not Including Serious) Adverse Events
	Initial Phase		Atorvastatin		Pravastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/317 (1.9%)		5/97 (5.2%)		7/92 (7.6%)		5/103 (4.9%)
Cardiac disorders
Tachycardia	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
Eye disorders
visual impairment	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
Gastrointestinal disorders
gingival hypoplasia	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Diarrhea	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
abdominal distension	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
abdominal pain	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Dyspepsia	0/317 (0%)		0/97 (0%)		2/92 (2.2%)		0/103 (0%)
Nausea	0/317 (0%)		0/97 (0%)		3/92 (3.3%)		0/103 (0%)
Vomiting	0/317 (0%)		0/97 (0%)		2/92 (2.2%)		0/103 (0%)
Immune system disorders
hypersensitivity	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Infections and infestations
fungal infection	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
lung infection	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
vaginal infection	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
Laryngitis	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Otitis externa	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Rhinitis	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
sinusitis	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Injury, poisoning and procedural complications
Joint Injury	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Metabolism and nutrition disorders
Gout	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/317 (0%)		1/97 (1%)		1/92 (1.1%)		0/103 (0%)
Muscle Spasms	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		2/103 (1.9%)
Back Pain	1/317 (0.3%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
Myalgia	0/317 (0%)		1/97 (1%)		0/92 (0%)		2/103 (1.9%)
Osteoarthritis	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
knee arthroplasty joint prosthesis user	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Nervous system disorders
Headache	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Morton's neuralgia	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Sciatica	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Reproductive system and breast disorders
benign prostatic hyperplasia	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
Respiratory, thoracic and mediastinal disorders
Laryngitis	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Ear Infection	1/317 (0.3%)		0/97 (0%)		0/92 (0%)		0/103 (0%)
Skin and subcutaneous tissue disorders
skin discolouration	0/317 (0%)		0/97 (0%)		1/92 (1.1%)		0/103 (0%)
erythema	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
Rash	0/317 (0%)		0/97 (0%)		0/92 (0%)		1/103 (1%)
Vascular disorders
venous insufficiency	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)
deep vein thrombosis	0/317 (0%)		1/97 (1%)		0/92 (0%)		0/103 (0%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If the PI wants to discuss or publish results after the trial is completed he must obtain writing authorization from AstraZeneca