Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)(COMPLETED)

This study has been completed.

Study NCT00653523 Information provided by Schering-Plough

First Received on April 1, 2008. Last Updated on August 12, 2010 History of Changes

Results First Received: May 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypercholesterolemia
Interventions:	Drug: Ezetimibe Drug: Simvastatin

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 + Simvastatin	Ezetimibe 10 mg + Simvastatin 20 mg level below what was specified in inclusion criterion level >2x upper limit of normal at start of treatment level >=3x upper limit of normal after start of treatment did not resolve or improve after dose reduction of simvastatin

Description

Ezetimibe + Simvastatin

Ezetimibe 10 mg + Simvastatin 20 mg

level below what was specified in inclusion criterion
level >2x upper limit of normal at start of treatment
level >=3x upper limit of normal after start of treatment
did not resolve or improve after dose reduction of simvastatin

Participant Flow: Overall Study

	Ezetimibe + Simvastatin
STARTED	151
COMPLETED	132
NOT COMPLETED	19
Drop in low density lipoprotein (1)	2
Elevated creatine phosphokinase (2)	1
Adverse Event	7
Withdrawal by Subject	6
Elevated alanine aminotransferase (3)	2
Adverse reaction did not improve (4)	1

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe + Simvastatin	Ezetimibe 10 mg + Simvastatin 20 mg

Baseline Measures

	Ezetimibe + Simvastatin
Number of Participants [units: participants]	151
Age, Customized ^[1] [units: Participants]	151
Gender [units: participants]
Female	82
Male	69
Region of Enrollment [units: participants]
Japan	151

[1]	Age 20 years and older

Outcome Measures

1. Primary:

Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ]

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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:

Principal Investigator (PI) agrees, for a period of 5 years following the Effective Date, to retain the Disclosure made to it by or on behalf of Sponsor (SPKK), in confidence and not to disclose it to any third party.

PI further agrees that during such time period it will not, either directly or indirectly, use the Disclosure for any purpose(s) other than that indicated herein without the prior written consent of SPKK.

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:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653523 History of Changes
Other Study ID Numbers:	P05457
Study First Received:	April 1, 2008
Results First Received:	May 27, 2010
Last Updated:	August 12, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency