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Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

This study has been completed.
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT00932620
First received: July 2, 2009
Last updated: August 17, 2011
Last verified: June 2011
Results First Received: June 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: SIMVASTATIN 40 mg
Drug: SIMVASTATIN/EZETIMIBE 10/10 mg

  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
Simvastatin 40 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
Simvastatin 10 mg Plus Ezetimibe 10 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily

Participant Flow:   Overall Study
    Simvastatin 40 mg     Simvastatin 10 mg Plus Ezetimibe 10 mg  
STARTED     50     50  
COMPLETED     50     50  
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
Simvastatin 40 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
Simvastatin 10 mg Plus Ezetimibe 10 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
Total Total of all reporting groups

Baseline Measures
    Simvastatin 40 mg     Simvastatin 10 mg Plus Ezetimibe 10 mg     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     45     44     89  
>=65 years     5     6     11  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 10     59  ± 9     58  ± 9  
Gender  
[units: participants]
     
Female     16     17     33  
Male     34     33     67  
Region of Enrollment  
[units: participants]
     
Greece     50     50     100  



  Outcome Measures
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1.  Primary:   Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels   [ Time Frame: Baseline and 3 months ]

2.  Secondary:   Changes in Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: 3 months ]


  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
Limitations of our study include its open-label design and the lack of clinical endpoints. However, all laboratory determinations were performed blindly with regard to treatment allocation.


  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: Prof Moses Elisaf
Organization: University of Ioannina
phone: +302651007509
e-mail: egepi@cc.uoi.gr


Publications of Results:

Responsible Party: Prof. M. Elisaf, University of Ioannina
ClinicalTrials.gov Identifier: NCT00932620     History of Changes
Other Study ID Numbers: 001
Study First Received: July 2, 2009
Results First Received: June 13, 2011
Last Updated: August 17, 2011
Health Authority: Greece: Ministry of Health and Welfare