Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

This study has been completed.

Study NCT00423488 Information provided by Schering-Plough

First Received on January 17, 2007. Last Updated on March 17, 2010 History of Changes

Results First Received: February 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease
Interventions:	Drug: Ezetimibe 10 mg Drug: Simvastatin 20 mg Drug: Ezetimibe Placebo Drug: Simvastatin Placebo

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 10 mg + Simvastatin Placebo + Simvastatin 20 mg	Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Ezetimibe Placebo + Simvastatin 40 mg	Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.

Participant Flow: Overall Study

	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg	Ezetimibe Placebo + Simvastatin 40 mg
STARTED	42	51
COMPLETED	37	50
NOT COMPLETED	5	1
No evidence of study drug intake	2	1
No post baseline data	3	0

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg	Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Ezetimibe Placebo + Simvastatin 40 mg	Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.

Baseline Measures

	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg	Ezetimibe Placebo + Simvastatin 40 mg	Total
Number of Participants [units: participants]	42	51	93
Age [units: years] Mean ± Standard Deviation	65.0 ± 6.5	63.9 ± 6.1	64.4 ± 6.3
Gender [units: participants]
Female	18	12	30
Male	24	39	63
Region of Enrollment [units: participants]
Italy	42	51	93

Outcome Measures

1. Primary:

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment [ Time Frame: 6 weeks of treatment (from Baseline to Endpoint) ]

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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: Investigator agrees not to publish or publicaly present results without prior written authorization from the sponsor, except than for the dispositions provided for in Ministerial Circular n.6 of 02 SEP 2002 and, particularly, disposition n.1a) The investigator further agrees to provide 30 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of material(including text for oral presentation) that report study results.

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:

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:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00423488 History of Changes
Other Study ID Numbers:	P04037
Study First Received:	January 17, 2007
Results First Received:	February 17, 2010
Last Updated:	March 17, 2010
Health Authority:	Italy: AIFA Agenzia Italiana del Farmaco- Rome