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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)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00631189
First received: February 28, 2008
Last updated: June 14, 2011
Last verified: June 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
Total Total of all reporting groups

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

9.  Secondary:   To Evaluate Clinical and Laboratory Safety   [ Time Frame: duration of study ]
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Measure Type Secondary
Measure Title To Evaluate Clinical and Laboratory Safety
Measure Description Serious Adverse Event and Adverse Event reported throughout the study
Time Frame duration of study  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Measured Values
    Initial Phase     Atorvastatin     Pravastatin     Rosuvastatin  
Number of Participants Analyzed  
[units: participants]
 		  317     97     92     103  
To Evaluate Clinical and Laboratory Safety  
[units: Adverse Events]
 		  8     9     8     5  

No statistical analysis provided for To Evaluate Clinical and Laboratory Safety



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:
unchecked 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.
unchecked 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.


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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)