Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00862251

First received: March 12, 2009

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Results First Received: February 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Cardiovascular Disorder Diabetes Mellitus
Interventions:	Drug: ezetimibe (+) simvastatin Drug: simvastatin 40 mg or atorvastatin 20 mg Drug: Rosuvastatin Drug: atorvastatin 10 mg or simvastatin 20 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ezetimibe/Simvastatin	Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
Doubling Statin Dose	simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Rosuvastatin	Rosuvastatin 10 mg tablets, taken once daily for six weeks.

Participant Flow: Overall Study

	Ezetimibe/Simvastatin	Doubling Statin Dose	Rosuvastatin
STARTED	322	162	324
COMPLETED	303	157	315
NOT COMPLETED	19	5	9
Adverse Event	8	3	1
Lost to Follow-up	0	0	1
Protocol Violation	2	0	1
Withdrawal by Subject	9	2	6

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe/Simvastatin	Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
Doubling Statin Dose	simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Rosuvastatin	Rosuvastatin 10 mg tablets, taken once daily for six weeks.
Total	Total of all reporting groups

Baseline Measures

	Ezetimibe/Simvastatin	Doubling Statin Dose	Rosuvastatin	Total
Number of Participants [units: participants]	322	162	324	808
Age [units: years] Mean ± Standard Deviation	64.1 ± 8.8	64.7 ± 8.3	63.6 ± 8.4	64.0 ± 8.5
Gender [units: participants]
Female	162	82	142	386
Male	160	80	182	422

Outcome Measures

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1. Primary:

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). [ Time Frame: Baseline and Week 6 ]

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2. Secondary:

In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin [ Time Frame: Baseline and Week 6 ]

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3. Secondary:

In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin [ Time Frame: Baseline and Week 6 ]

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4. Secondary:

Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin [ Time Frame: Baseline and Week 6 ]

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5. Secondary:

Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]

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6. Secondary:

In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]

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7. Secondary:

In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]

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8. Secondary:

Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ]

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9. Secondary:

Percent Change From Baseline in Triglycerides [ Time Frame: Baseline and Week 6 ]

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10. Secondary:

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ]

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11. Secondary:

Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ]

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12. Secondary:

Percent Change From Baseline in LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]

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13. Secondary:

Percent Change From Baseline in TC/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]

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14. Secondary:

Percent Change From Baseline in Non-HDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]

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15. Secondary:

Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 6 ]

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16. Secondary:

Percent Change From Baseline Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and Week 6 ]

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17. Secondary:

Percent Change From Baseline in Apo B/Apo A-I Ratio [ Time Frame: Baseline and Week 6 ]

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18. Secondary:

Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline and Week 6 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: An investigator and/or his/her colleagues may publish the results for their study site independently after the multicenter publication, or 24 months after completion of the study, whichever comes first. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

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
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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

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00862251 History of Changes
Other Study ID Numbers:	MK-0653A-133, 2009_559
Study First Received:	March 12, 2009
Results First Received:	February 23, 2012
Last Updated:	March 26, 2012
Health Authority:	United States: Food and Drug Administration

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