Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)(COMPLETED)

This study has been completed.

Study NCT00654095 Information provided by Schering-Plough

First Received on April 1, 2008. Last Updated on November 18, 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: atorvastatin

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
Participants did not Complete the Study: level below what was specified in inclusion criterion level >500 mg/dL at start of treatment level >2x upper limit of normal at start of treatment level >=3x upper limit of normal after start of treatment Adverse reactions did not improve or resolve after dose reduction of atorvastatin

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Participants did not Complete the Study:

level below what was specified in inclusion criterion
level >500 mg/dL at start of treatment
level >2x upper limit of normal at start of treatment
level >=3x upper limit of normal after start of treatment
Adverse reactions did not improve or resolve after dose reduction of atorvastatin

Reporting Groups

	Description
Ezetimibe + Atorvastatin	Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily

Participant Flow: Overall Study

	Ezetimibe + Atorvastatin
STARTED	146
COMPLETED	114
NOT COMPLETED	32
Drop in low density lipoprotein (1)	2
Elevated triglyceride level (2)	1
Elevated alanine aminotransferase (3)	1
Adverse Event	11
Withdrawal by Subject	5
Elevated alanine aminotransferase (4)	7
Adverse reaction did not improve (5)	4
Did not meet inclusion criteria	1

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe + Atorvastatin	Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily

Baseline Measures

	Ezetimibe + Atorvastatin
Number of Participants [units: participants]	146
Age, Customized ^[1] [units: Participants]	146
Gender [units: participants]
Female	79
Male	67
Region of Enrollment [units: participants]
Japan	146

[1]	>=20 Years

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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00654095 History of Changes
Other Study ID Numbers:	P05456
Study First Received:	April 1, 2008
Results First Received:	May 27, 2010
Last Updated:	November 18, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency