Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

This study has been completed.

Study NCT00319449 Information provided by Schering-Plough

First Received on April 28, 2006. Last Updated on April 14, 2011 History of Changes

Results First Received: April 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Hypercholesterolemia Coronary Arteriosclerosis
Interventions:	Drug: Ezetimibe Drug: Placebo Drug: Atorvastatin 10 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 10 mg	Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
Placebo 10 mg	Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

Participant Flow: Overall Study

	Ezetimibe 10 mg	Placebo 10 mg
STARTED	10	12
COMPLETED	8	12
NOT COMPLETED	2	0
Subject did not wish to continue	1	0
Noncompliance with the protocol	1	0

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe 10 mg	Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
Placebo 10 mg	Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

Baseline Measures

	Ezetimibe 10 mg	Placebo 10 mg	Total
Number of Participants [units: participants]	10	12	22
Age [units: Years] Mean ± Standard Deviation	57.4 ± 12.1	52.2 ± 10.4	54.5 ± 11.3
Age, Customized [units: Participants]
18 to <65 years	7	11	18
65 or older	3	1	4
Gender [units: participants]
Female	3	5	8
Male	7	7	14
Region of Enrollment [units: participants]
Indonesia	10	12	22

Outcome Measures

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1. Primary:

Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg [ Time Frame: Baseline and 6 weeks ]

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2. Secondary:

Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL) [ Time Frame: 6 weeks post treatment ]

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3. Secondary:

High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg [ Time Frame: 6 weeks post treatment ]

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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 principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The PI further agrees to provide thirty (30) days written notice to the SPONSOR prior to submission for publication or presentation to allow SPONSOR to review abstracts or manuscripts for publication.

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
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group leader
Organization: Merck Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00319449 History of Changes
Other Study ID Numbers:	P04060
Study First Received:	April 28, 2006
Results First Received:	April 14, 2011
Last Updated:	April 14, 2011
Health Authority:	Indonesia: National Agency of Drug and Food Control