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

Tracking Information
First Received Date ^ICMJE	May 20, 2009
Last Updated Date	August 31, 2011
Start Date ^ICMJE	November 2006
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2011)	Number of Participants Who Had an Adverse Event (AE). [ Time Frame: Throughout study up to Day 29 (Final Visit) ] [ Designated as safety issue: Yes ] The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
Original Primary Outcome Measures ^ICMJE (submitted: May 27, 2009)	To evaluate the overall safety and tolerability of Vytorin Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia [ Time Frame: Day 29 (Final Visit) ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00909389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)(COMPLETED)
Official Title ^ICMJE	Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients
Brief Summary	This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients 18 years old and above seen in the outpatient clinic who were diagnosed to have hypercholesterolemia. Patients with primary (heterozygous familial and non - familial) hypercholesterolemia or homozygous familial hypercholesterolemia were also included.
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: Vytorin (R) (Ezetimibe + Simvastatin) Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days Other Name: SCH 465981
Study Group/Cohort (s)	Filipino Patients with Hypercholesterolemia Intervention: Drug: Vytorin (R) (Ezetimibe + Simvastatin)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	4748
Completion Date	November 2008
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Outpatient men or women, age 18 years and above Patients with primary (heterozygous familial and non-familial) hypercholesterolemia Exclusion Criteria: Known hypersensitivity to Ezetimibe and Simvastatin Moderate to severe hepatic insufficiency Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal Pregnancy or lactation Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00909389
Other Study ID Numbers ^ICMJE	P05647
Has Data Monitoring Committee	No
Responsible Party	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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