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 - Study Results

Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients (CAP-Chol)

This study has been completed.

Study NCT00631189 Information provided by AstraZeneca

First Received on February 28, 2008. Last Updated on June 14, 2011 History of Changes

Results First Received: March 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type IIa and IIb Hypercholesterolaemia
Interventions:	Drug: Rosuvastatin Drug: Pravastatin Drug: Atorvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited by general practitioner. First patient included: 12 October 2007 Last patient terminated the study: 04 October 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Initial Phase	Initial phase (between V1 and V2)
Atorvastatin	Atorvastatin 10 mg
Pravastatin	Pravastatin 40 mg
Rosuvastatin	Rosuvastatin 5 mg

Participant Flow for 2 periods

Period 1: Initial Phase

	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
STARTED	668	0 ^[1]	0 ^[1]	0 ^[1]
COMPLETED	317	0 ^[1]	0 ^[1]	0 ^[1]
NOT COMPLETED	351	0	0	0
Protocol Violation	347	0	0	0
Withdrawal by Subject	4	0	0	0

[1]	Not applicable

Period 2: Treatment Phase

	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin
STARTED	0 ^[1]	104	103	110
COMPLETED	0 ^[1]	97	92	103
NOT COMPLETED	0	7	11	7
Withdrawal by Subject	0	2	1	1
Protocol Violation	0	1	6	2
Adverse Event	0	3	2	4
Lost to Follow-up	0	1	0	0
Pregnancy	0	0	1	0
patient did not take pravastatin	0	0	1	0

[1]	not applicable

Baseline Characteristics

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Reporting Groups

	Description
Initial Phase	Initial phase (between V1 and V2)
Atorvastatin	Atorvastatin 10 mg
Pravastatin	Pravastatin 40 mg
Rosuvastatin	Rosuvastatin 5 mg

Baseline Measures

	Initial Phase	Atorvastatin	Pravastatin	Rosuvastatin	Total
Number of Participants [units: participants]	0	104	103	110	317
Age [units: years] Mean ± Standard Deviation		57.31 ± 10.59	57.23 ± 10.8	57.04 ± 9.32	57.18 ± 9.95
Gender [units: Participants]
Female		49	55	46	unknown
Male		55	48	64	unknown

Outcome Measures

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1. Primary:

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

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks [ Time Frame: Baseline and after 8 weeks of treatment ]

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5. Secondary:

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 ]

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6. Secondary:

Compare the Percentage of Variation of C-reactive Protein (CRP) [ Time Frame: baseline and after 8 weeks of treatment ]

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7. Secondary:

Compare the Percentage of Variation of Phospholipase A2 (PLA2) [ Time Frame: from baseline and after 8 weeks of treatment ]

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8. 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 [ Time Frame: from baseline and after 8 weeks of treatment ]

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9. Secondary:

To Evaluate Clinical and Laboratory Safety [ Time Frame: duration of study ]

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10. 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 [ Time Frame: Not done ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

11. 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 [ Time Frame: Not done ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

12. 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 [ Time Frame: n/a ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If the PI wants to discuss or publish results after the trial is completed he must obtain writing authorization from AstraZeneca

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Elisabeth Björk / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00631189 History of Changes
Other Study ID Numbers:	D3560L00068, EudraCT No 2006-006697-15
Study First Received:	February 28, 2008
Results First Received:	March 11, 2010
Last Updated:	June 14, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency