Trial record 3 of 54 for:    mk-0653c

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01154036
First received: June 29, 2010
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: ezetimibe 10 mg
Drug: atorvastatin
Drug: Comparator: rosuvastatin

  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
Participants in the Atorvastatin 20mg and Rosuvastatin 10mg arms who did not meet low density lipoprotein-cholesterol goals during Phase I were eligible for Phase II. Approximately 25% of participants in the ezetimibe 10mg+atorvastatin10mg arm continued to Phase II regardless of LDL-C control but were not included in any of the statistical analyses

Reporting Groups
  Description
Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Phase I: Atorvastatin 20 mg Atorvastatin 20 mg tablet once daily for 6 weeks
Phase I: Rosuvastatin 10 mg Rosuvastatin 10 mg tablet once daily for 6 weeks;
Phase II: EZ 10mg+Atorva 10mg Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Phase II: EZ 10mg + Atorva 20mg [A] Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Phase II: Atorva 40mg Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
Phase II: EZ 10mg + Atorva 20mg [R] Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Phase II: Rosuvastatin 20mg Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II

Participant Flow for 2 periods

Period 1:   Phase I
    Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg     Phase I: Atorvastatin 20 mg     Phase I: Rosuvastatin 10 mg     Phase II: EZ 10mg+Atorva 10mg     Phase II: EZ 10mg + Atorva 20mg [A]     Phase II: Atorva 40mg     Phase II: EZ 10mg + Atorva 20mg [R]     Phase II: Rosuvastatin 20mg  
STARTED     120     483     944     0     0     0     0     0  
COMPLETED     117 [1]   455 [1]   888 [1]   0     0     0     0     0  
NOT COMPLETED     3     28     56     0     0     0     0     0  
Physician Decision                 0                 1                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 3                 6                 0                 0                 0                 0                 0  
Protocol Violation                 0                 3                 9                 0                 0                 0                 0                 0  
Withdrawal by Subject                 2                 10                 29                 0                 0                 0                 0                 0  
Adverse Event                 1                 11                 12                 0                 0                 0                 0                 0  
[1] Not all completers were eligible for Phase II

Period 2:   Phase II
    Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg     Phase I: Atorvastatin 20 mg     Phase I: Rosuvastatin 10 mg     Phase II: EZ 10mg+Atorva 10mg     Phase II: EZ 10mg + Atorva 20mg [A]     Phase II: Atorva 40mg     Phase II: EZ 10mg + Atorva 20mg [R]     Phase II: Rosuvastatin 20mg  
STARTED     0     0     0     28 [1]   124 [1]   126 [1]   234 [1]   206 [1]
COMPLETED     0     0     0     27     116     121     225     200  
NOT COMPLETED     0     0     0     1     8     5     9     6  
Adverse Event                 0                 0                 0                 0                 1                 1                 1                 1  
Physician Decision                 0                 0                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 1                 2                 0                 2                 1  
Protocol Violation                 0                 0                 0                 0                 1                 2                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 4                 2                 5                 4  
[1] Only participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II



  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
Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Phase I: Atorvastatin 20 mg Atorvastatin 20 mg tablet once daily for 6 weeks
Phase I: Rosuvastatin 10 mg Rosuvastatin 10 mg tablet once daily for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg     Phase I: Atorvastatin 20 mg     Phase I: Rosuvastatin 10 mg     Total  
Number of Participants  
[units: participants]
  120     483     944     1547  
Age, Customized  
[units: Participants]
       
<20 years     0     0     1     1  
20 to 29 years     0     4     2     6  
30 to 39 years     1     13     25     39  
40 to 49 years     16     50     99     165  
50 to 59 years     37     170     324     531  
60 to 64 years     27     87     183     297  
≥65 years     39     159     310     508  
Gender  
[units: Participants]
       
Female     71     253     489     813  
Male     49     230     455     734  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I ) ]

2.  Secondary:   Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).   [ Time Frame: Baseline (Week 6) and Week 12 ]

3.  Secondary:   Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)   [ Time Frame: Week 6 (End of Phase I) ]

4.  Secondary:   Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)   [ Time Frame: Week 12 (End of Phase II) ]

5.  Secondary:   Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)   [ Time Frame: Week 6 (End of Phase I) ]

6.  Secondary:   Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)   [ Time Frame: Week 12 (end of Phase II) ]

7.  Secondary:   Percent Change From Baseline in Total Cholesterol (TC) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol (TC) (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ]

9.  Secondary:   Percent Change From Baseline in Triglycerides (TG) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

10.  Secondary:   Percent Change From Baseline in Triglycerides (TG) (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ]

11.  Secondary:   Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

12.  Secondary:   Percent Change From Baseline in HDL-C (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ]

13.  Secondary:   Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

14.  Secondary:   Percent Change From Baseline in Apo B (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]

15.  Secondary:   Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

16.  Secondary:   Percent Change From Baseline in Apo A-I (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ]

17.  Secondary:   Percent Change From Baseline in Non-HDL-C (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

18.  Secondary:   Percent Change From Baseline in Non-HDL-C (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ]

19.  Secondary:   Percent Change From Baseline in TC/HDL-C Ratio (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

20.  Secondary:   Percent Change From Baseline in TC/HDL-C Ratio (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]

21.  Secondary:   Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

22.  Secondary:   Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]

23.  Secondary:   Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

24.  Secondary:   Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]

25.  Secondary:   Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

26.  Secondary:   Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]

27.  Secondary:   Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)   [ Time Frame: Baseline and Week 6 (end of Phase I) ]

28.  Secondary:   Percent Change From Baseline in Hs-CRP (Phase II)   [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01154036     History of Changes
Other Study ID Numbers: 0653C-162, 2010_517
Study First Received: June 29, 2010
Results First Received: September 5, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration