Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00909389

First received: May 20, 2009

Last updated: August 31, 2011

Last verified: August 2011

History of Changes

Results First Received: June 24, 2009

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Hypercholesterolemia
Intervention:	Drug: Vytorin (R) (Ezetimibe + 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
Filipino Patients With Hypercholesterolemia	No text entered.

Participant Flow: Overall Study

	Filipino Patients With Hypercholesterolemia
STARTED	4748
COMPLETED	4615
NOT COMPLETED	133
Adverse Event	6
Death	4
Poor Compliance	16
Lost to Follow-up	4
No Information	103

Baseline Characteristics

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Reporting Groups

	Description
Filipino Patients With Hypercholesterolemia	No text entered.

Baseline Measures

	Filipino Patients With Hypercholesterolemia
Number of Participants [units: participants]	4748
Age [units: years] Mean ± Standard Deviation	55.53 ± 11.71
Gender [units: participants]
Female	2400
Male	2348

Outcome Measures

1. Primary:

Number of Participants Who Had an Adverse Event (AE). [ Time Frame: Throughout study up to Day 29 (Final Visit) ]

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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: Other disclosures agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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@merck.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00909389 History of Changes
Other Study ID Numbers:	P05647
Study First Received:	May 20, 2009
Results First Received:	June 24, 2009
Last Updated:	August 31, 2011
Health Authority:	Philippines: Bureau of Food and Drugs

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