Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

This study has been completed.

Study NCT00782184 Information provided by Merck

First Received on October 29, 2008. Last Updated on September 22, 2011 History of Changes

Results First Received: September 22, 2011

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/simvastatin 10/40 Drug: atorvastatin 40 mg Drug: atorvastatin 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
Participants received 20 mg open-label atorvastatin during a 5-week run-in period.

Reporting Groups

	Description
Ezetimibe/Simvastatin 10/40	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
Atorvastatin 40 mg	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.

Participant Flow: Overall Study

	Ezetimibe/Simvastatin 10/40	Atorvastatin 40 mg
STARTED	120	130
COMPLETED	116	125
NOT COMPLETED	4	5
Adverse Event	1	2
Protocol Violation	0	1
Withdrawal by Subject	3	2

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe/Simvastatin 10/40	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
Atorvastatin 40 mg	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.

Baseline Measures

	Ezetimibe/Simvastatin 10/40	Atorvastatin 40 mg	Total
Number of Participants [units: participants]	120	130	250
Age [units: years] Mean ± Standard Deviation	58.9 ± 10.0	59.7 ± 8.4	59.3 ± 9.2
Gender [units: participants]
Female	57	65	122
Male	63	65	128

Outcome Measures

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1. Primary:

Percent Change From Baseline in Low Density Lipoprotein (LDL)-C [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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2. Secondary:

Number of Participants Reaching LDL-C Target Goals of <70 mg/dL [ Time Frame: Treatment Week 6 ]

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3. Secondary:

Number of Participants Reaching LDL-C Target Goal <77 mg/dL [ Time Frame: Treatment Week 6 ]

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4. Secondary:

Number of Participants Reaching LDL-C Target Goal <100 mg/dL [ Time Frame: Treatment Week 6 ]

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5. Secondary:

Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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6. Secondary:

Percent Change From Baseline in Triglycerides [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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7. Secondary:

Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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8. Secondary:

Percent Change From Baseline in Non-HDL Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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9. Secondary:

Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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10. Secondary:

Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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11. Secondary:

Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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12. Secondary:

Percent Change From Baseline in Apolipoprotein B [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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13. Secondary:

Percent Change From Baseline in Apolipoprotein A-1 [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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14. Secondary:

Percent Change From Baseline in Apolipoprotein B/A-1 Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

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15. Secondary:

Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: Baseline (Treatment Day 1), Treatment 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: 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. Sponsor review can be expedited to meet publication guidelines.

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:	NCT00782184 History of Changes
Other Study ID Numbers:	MK-0653A-134, 2008_576
Study First Received:	October 29, 2008
Results First Received:	September 22, 2011
Last Updated:	September 22, 2011
Health Authority:	United States: Food and Drug Administration