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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

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ClinicalTrials.gov Identifier: NCT00819403
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Miller, University of Maryland, College Park

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Metabolic Syndrome
Interventions Drug: simvastatin
Drug: ezetimibe/simvastatin
Enrollment 15
Recruitment Details All patients have been recruited and 15 have successfully completed the study.
Pre-assignment Details Patients excluded included those unable to tolerate statin and/or ezetimibe treatment
Arm/Group Title Simvastatin Then Simvastatin/Ezetimibe Simvastatin/Ezetimibe Then Simvastatin
Hide Arm/Group Description

Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily

Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
Period Title: First Intervention (6 Weeks)
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Washout (14 Days)
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Second Intervention (6 Weeks)
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Simvastatin Simvastatin/Ezetimibe Total
Hide Arm/Group Description

Simvastatin 40 mg daily

simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

Total of all reporting groups
Overall Number of Baseline Participants 7 8 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
8
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 15 participants
46.3  (6.6) 50.5  (12.6) 48.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
Female
4
  57.1%
3
  37.5%
7
  46.7%
Male
3
  42.9%
5
  62.5%
8
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 8 participants 15 participants
7 8 15
1.Primary Outcome
Title Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
Hide Description Measured using whole blood flow cytometry
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Based on power calculations
Arm/Group Title Simvastatin Simvastatin/Ezetimibe
Hide Arm/Group Description:
Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ng/dl
PAR 1/4 antigen 35.4  (5.2) 34.5  (5.4)
PAR 1/4 activity 23.6  (4.3) 22.5  (6.2)
2.Secondary Outcome
Title Biomarkers of Inflammation
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Simvastatin/Ezetimibe
Hide Arm/Group Description:
Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dl
CRP 3.51  (.48) 3.57  (.34)
IL-6 1.24  (.12) 1.33  (.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Simvastatin/Ezetimibe
Hide Arm/Group Description

Simvastatin 40 mg daily

simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

All-Cause Mortality
Simvastatin Simvastatin/Ezetimibe
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Simvastatin/Ezetimibe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin Simvastatin/Ezetimibe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      1/15 (6.67%)    
Gastrointestinal disorders     
GI symptoms * [1]  2/15 (13.33%)  3 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Muscle symptoms * [2]  4/15 (26.67%)  4 0/15 (0.00%)  0
Psychiatric disorders     
Fatigue *  2/15 (13.33%)  2 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Gas, bloating, change in bowel movements
[2]
Aches, cramps
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
Layout table for Results Point of Contact information
Name/Title: Dr Michael Miller
Organization: Univ Maryland
Phone: 410 328-6299
EMail: mmiller@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: Michael Miller, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT00819403     History of Changes
Other Study ID Numbers: HP-00040970
MSP-JV IISP #32031
First Submitted: January 7, 2009
First Posted: January 9, 2009
Results First Submitted: February 27, 2013
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014