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Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481351
First Posted: June 1, 2007
Last Update Posted: January 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
Results First Submitted: January 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 reported.   Anticipated Reporting Date:   07/2011  

7.  Secondary:   Triglyceride Fractional Clearance Rate   [ Time Frame: 6week ]
Results not yet reported.   Anticipated Reporting Date:   11/2010  


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otavio Celeste Mangili, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00481351     History of Changes
Other Study ID Numbers: 1068/06
First Submitted: May 30, 2007
First Posted: June 1, 2007
Results First Submitted: January 7, 2011
Results First Posted: January 26, 2011
Last Update Posted: January 26, 2011



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