Text Size

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
  Purpose

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.


Condition Intervention
Hypercholesterolemia
 Drug: Vytorin (R) (Ezetimibe + Simvastatin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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.



Enrollment: 4748
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Filipino Patients with 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013