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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg
This study has been completed.
Study NCT00276484   Information provided by Merck
First Received: January 11, 2006   Last Updated: October 23, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition: Hypercholesterolemia
Interventions: Drug: atorvastatin
Drug: ezetimibe

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Atorvastatin + Ezetemibe Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin Atorvastatin 80 mg every day for 6 weeks

Baseline Measures
  Atorvastatin + Ezetemibe Atorvastatin Total
Number of Participants  
[units: participants]
288 291 579
Age  
[units: years]
Mean ( Full Range )
60.6
( 31 to 80 )
62
( 34 to 79 )
61.3
( 31 to 80 )
Gender  
[units: participants]
     
Female 115 113 228
Male 173 178 351
Race/Ethnicity, Customized  
[units: Participants]
     
White 237 232 469
Asian 4 8 12
Black 32 29 61
Multi-Racial 15 22 37
Apolipoprotein A-I  
[units: mg/dL]
Mean ± Standard Deviation
154.0 ± 25.5 154.6 ± 25.0 154.3 ± 25.3
Apolipoprotein B  
[units: mg/dL]
Mean ± Standard Deviation
101.3 ± 19.0 102.0 ± 18.8 101.7 ± 18.9
Apolipoprotein B:Apolipoprotein A-I ratio  
[units: Ratio]
Mean ± Standard Deviation
0.7 ± 0.2 0.7 ± 0.2 0.7 ± 0.2
C Reactive Protein  
[units: mg/dL]
Mean ± Standard Deviation
1.8 ± 2.7 1.5 ± 3.0 1.6 ± 2.8
High-Density Lipoprotein  
[units: mg/dL]
Mean ± Standard Deviation
47.4 ± 10.5 47.2 ± 10.6 47.3 ± 10.5
Low-Density Lipoprotein  
[units: mg/dL]
Mean ± Standard Deviation
88.8 ± 16.2 89.8 ± 16.2 89.4 ± 16.2
Low-Density Lipoprotein-C:High-Density Lipoprotein-C ratio  
[units: Ratio]
Mean ± Standard Deviation
2.0 ± 0.6 2.0 ± 0.6 2.0 ± 0.6
Non-High-Density Lipoprotein Cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
117.7 ± 20.8 118.1 ± 21.9 117.9 ± 21.4
Non-High-Density Lipoprotein-C:High-Density Lipoprotein-C ratio  
[units: Ratio]
Mean ± Standard Deviation
2.6 ± 0.8 2.6 ± 0.8 2.6 ± 0.8
Total Cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
165.2 ± 21.4 165.3 ± 22.8 165.2 ± 22.1
Total cholesterol:High-Density Lipoprotein-C ratio  
[units: Ratio]
Mean ± Standard Deviation
3.6 ± 0.8 3.6 ± 0.8 3.6 ± 0.8
Triglycerides  
[units: mg/dL]
Median ± Standard Deviation
132.5 ± 72.1 134.0 ± 72.1 133.5 ± 72.1



  Outcome Measures
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1.  Primary:   Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C   [ Baseline and 6 weeks ]

2.  Secondary:   Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)   [ Baseline and 6 weeks ]

3.  Secondary:   Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)   [ Baseline and 6 Weeks ]

4.  Secondary:   Percent Change From Baseline to Week 6 in Total-Cholesterol   [ Baseline and 6 Weeks ]

5.  Secondary:   Percent Change From Baseline to Week 6 in Triglycerides (TG)   [ Baseline and 6 Weeks ]

6.  Secondary:   Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)   [ Baseline and 6 Weeks ]

7.  Secondary:   Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)   [ Baseline and 6 Weeks ]

8.  Secondary:   Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio   [ Baseline and 6 Weeks ]

9.  Secondary:   Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio   [ Baseline and 6 Weeks ]

10.  Secondary:   Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio   [ Baseline and 6 Weeks ]

11.  Secondary:   Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio   [ Baseline and 6 Weeks ]

12.  Secondary:   Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)   [ Baseline and 6 Weeks ]

13.  Secondary:   Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6   [ 6 Weeks ]


  Serious Adverse Events
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  Other Adverse Events
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372


Publications:

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_105, MK0653-090
Study First Received: January 11, 2006
Results First Received: February 6, 2009
Last Updated: October 23, 2009
ClinicalTrials.gov Identifier: NCT00276484     History of Changes
Health Authority: United States: Food and Drug Administration