The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

This study has been completed.

Study NCT00423579 Information provided by Schering-Plough

First Received: January 17, 2007 Last Updated: October 13, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Conditions:	Hypercholesterolemia Coronary Disease
Interventions:	Drug: Ezetimibe/Simvastatin 10/20 mg Drug: simvastatin 40 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
Visits 1 and 2 were for screening, combined if wash-out not required. One ineligible subject mistakenly received assignment at Visit 2 and was removed. The subject did not receive treatment. Actual enrollment: 120 subjects. Intent-to-treat (ITT) population included only evaluable subjects; as such analysis based on 112 subjects.

Reporting Groups

	Description
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Participant Flow: Overall Study

	Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
STARTED	60^[1]	60
COMPLETED	56^[2]	56^[3]
NOT COMPLETED	4	4
Lost to Follow-up	3	0
Protocol Violation	1	3
Diagnosis of diabetes	0	1

[1]	61 enrolled, however one subject was ineligible and was removed.
[2]	These 56 subjects were the Intent-to-Treat population. Analysis based on ITT population.
[3]	These 56 subjects were the Intent-to-Treat population. Analysis based on ITT population.

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Baseline Measures

	Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Total
Number of Participants [units: participants]	56	56	112
Age^[1] [units: years] Mean ± Standard Deviation	61.3 ± 8.4	62.1 ± 7.8	61.7 ± 8.1
Gender^[2] [units: participants]
Female	26	24	50
Male	30	32	62

[1]	Mean age based on Intent-to-Treat population.
[2]	Gender totals based on Intent-to-Treat population.

Outcome Measures

1. Primary:

Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks [ Baseline and 6 weeks ]

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Measure Type	Primary
Measure Title	Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks
Measure Description	Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.
Time Frame	Baseline and 6 weeks
Safety Issue	No

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.
Intent-to-treat population only.

Reporting Groups

	Description
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Measured Values

	Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
Number of Participants Analyzed [units: participants]	56	56
Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks [units: percentage change] Mean ± Standard Deviation	-26.5 ± 9.5	-11.9 ± 13.6

Statistical Analysis 1 for Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks

Groups ^[1]	All groups
Method ^[2]	Student's t test for independent data
P Value ^[3]	0.0000
Mean Difference (Net) ^[4]	-14.5
95% Confidence Interval	( -18.9 to -10.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
	Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe [EZ]/Simvastatin [S] [10/20mg] + S [placebo] group minus the EZ/S [10mg/placebo] + S [40mg] group)

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 investigator shall not publish or publicly present the study results without prior written authorization from the sponsor, except for dispositions in the Ministerial Circular n. 6 dated 02 SEP 2002. The investigator shall notify the sponsor in writing of any publication submission or presentation reporting results of the study 30 days prior to submission or presentation to permit sponsor review.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Patrizia Favini, MD - Medical Director, Italy Country Operations )
Study ID Numbers:	P04039
Study First Received:	January 17, 2007
Results First Received:	March 19, 2009
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00423579 History of Changes
Health Authority:	Italy: Ministry of Health