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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00909389
First received: May 20, 2009
Last updated: November 14, 2014
Last verified: November 2014

May 20, 2009
November 14, 2014
November 2006
November 2008   (final data collection date for primary outcome measure)
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.

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 ]
Complete list of historical versions of study NCT00909389 on ClinicalTrials.gov Archive Site
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Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Hypercholesterolemia
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
Filipino Patients with Hypercholesterolemia
Intervention: Drug: Vytorin (R) (Ezetimibe + Simvastatin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4748
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00909389
P05647
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP