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 on January 17, 2007. Last Updated on October 13, 2009 History of Changes

Results First Received: March 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
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 ^[2]
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.

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 [ Time Frame: Baseline and 6 weeks ]

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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 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 by Schering-Plough

Publications automatically indexed to this study:

Averna M, Zaninelli A, Le Grazie C, Gensini GF. Ezetimibe/simvastatin 10/20 mg versus simvastatin 40 mg in coronary heart disease patients. J Clin Lipidol. 2010 Jul-Aug;4(4):272-8. Epub 2010 Jun 1.

Rotella CM, Zaninelli A, Le Grazie C, Hanson ME, Gensini GF. Ezetimibe/simvastatin vs simvastatin in coronary heart disease patients with or without diabetes. Lipids Health Dis. 2010 Jul 27;9:80.

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