Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00481351
First received: May 30, 2007
Last updated: January 7, 2011
Last verified: January 2007
Results First Received: January 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Heart Disease
Interventions: Drug: Simvastatin 20mg plus ezetimibe 10mg
Drug: ezetimibe
Drug: simvastatin 20mg
Drug: Simvastatin 80mg

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
group1 Ezetimibe 6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
Group 2 Simvastatin 6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.

Participant Flow:   Overall Study
    group1 Ezetimibe     Group 2 Simvastatin  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
group1 Ezetimibe 6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
Group 2 Simvastatin 6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
Total Total of all reporting groups

Baseline Measures
    group1 Ezetimibe     Group 2 Simvastatin     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     12     21  
>=65 years     4     0     4  
Age  
[units: years]
Mean ± Standard Deviation
  61.23  ± 6.4     60.08  ± 3.42     60.68  ± 4.96  
Gender  
[units: participants]
     
Female     3     3     6  
Male     10     9     19  
Waist  
[units: cm]
Median ± Standard Deviation
  94.85  ± 9.18     97.08  ± 8.63     95.92  ± 8.81  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation
  27.11  ± 3.41     27.96  ± 3.63     27.96  ± 3.63  
alanine aminotransferase  
[units: mg/dl]
Mean ± Standard Deviation
  24.23  ± 11.54     20  ± 4.88     22.2  ± 9.06  
Glucose  
[units: mg/dl]
Mean ± Standard Deviation
  93.46  ± 9.40     102.17  ± 11.39     97.64  ± 11.10  
Apolipoprotein A  
[units: mg/dl]
Mean ± Standard Deviation
  139.18  ± 29.36     136.5  ± 30.66     137.89  ± 29.39  
Apolipoprotein B  
[units: mg/dl]
Median ± Standard Deviation
  123.67  ± 32.99     115.74  ± 19.37     119.86  ± 27.06  
Total cholesterol  
[units: mg/dl]
Mean ± Standard Deviation
  222.54  ± 24.35     215.33  ± 33.32     219.08  ± 28.61  
Low Density Lipoprotein  
[units: mg/dl]
Median ± Standard Deviation
  141.85  ± 21.91     139.42  ± 22.19     140.68  ± 21.61  
High Density Lipoprotein  
[units: mg/dl]
Mean ± Standard Deviation
  48.08  ± 11.88     45.08  ± 13.04     46.64  ± 12.28  
Triglycerides  
[units: mg/dl]
Mean ± Standard Deviation
  165.23  ± 80.76     213.75  ± 112.85     188.52  ± 19.60  
cholesteryl ester fractional clearance rate  
[units: min-1]
Mean ± Standard Deviation
  0.0051  ± 0.0046     0.0046  ± 0.0029     0.0048576  ± 0.00381  
triglycerides fractional clearance rate  
[units: min-1]
Mean ± Standard Deviation
  0.0171  ± 0.0108     0.0161  ± 0.0096     0.016602  ± 0.01004  



  Outcome Measures
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1.  Primary:   Low Density Lipoprotein   [ Time Frame: 12week ]

2.  Secondary:   Alanine Aminotransferase   [ Time Frame: 12 weeks ]

3.  Secondary:   CPK   [ Time Frame: 12 week ]

4.  Secondary:   Total Cholesterol   [ Time Frame: 12 week ]

5.  Secondary:   High Density Lipoprotein   [ Time Frame: 12 week ]

6.  Primary:   Cholesteryl Ester Fractional Clearance Rate   [ Time Frame: 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   07/2011   Safety Issue:   No

7.  Secondary:   Triglyceride Fractional Clearance Rate   [ Time Frame: 6week ]
Results not yet posted.   Anticipated Posting Date:   11/2010   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Otavio Celeste Mangili, MD
Organization: Universidade de São Paulo
phone: +554499928818
e-mail: otaviomangili@yahoo.com.br


No publications provided


Responsible Party: Otavio Celeste Mangili, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00481351     History of Changes
Other Study ID Numbers: 1068/06
Study First Received: May 30, 2007
Results First Received: January 7, 2011
Last Updated: January 7, 2011
Health Authority: Brazil: National Committee of Ethics in Research