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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00909389
Collaborator
(none)
4,748
Enrollment
24
Duration (Months)

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Drug: Vytorin (R) (Ezetimibe + Simvastatin)

Study Design

Study Type:
Observational
Actual Enrollment :
4748 participants
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
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • SCH 465981

    		•

    Outcome Measures

    Primary Outcome Measures

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

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00909389
    Other Study ID Numbers:
    • P05647
    First Posted:
    May 28, 2009
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Simvastatin
    Ezetimibe
    Ezetimibe, Simvastatin Drug Combination

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Filipino Patients With Hypercholesterolemia
    Arm/Group Description
    Period Title: Overall Study
    STARTED 4748
    COMPLETED 4615
    NOT COMPLETED 133

    Baseline Characteristics

    Arm/Group Title Filipino Patients With Hypercholesterolemia
    Arm/Group Description
    Overall Participants 4748
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.53
    (11.71)
    Sex: Female, Male (Count of Participants)
    Female
    2400
    50.5%
    Male
    2348
    49.5%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Had an Adverse Event (AE).
    Description 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.
    Time Frame Throughout study up to Day 29 (Final Visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Filipino Patients With Hypercholesterolemia
    Arm/Group Description
    Measure Participants 4748
    Number [participants]
    62
    1.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Filipino Patients With Hypercholesterolemia
    Arm/Group Description
    All Cause Mortality
    Filipino Patients With Hypercholesterolemia
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Filipino Patients With Hypercholesterolemia
    Affected / at Risk (%) # Events
    Total 4/4748 (0.1%)
    Cardiac disorders
    Myocardial infarction 1/4748 (0%) 1
    General disorders
    Death 2/4748 (0%) 2
    Multi-organ failure 1/4748 (0%) 1
    Other (Not Including Serious) Adverse Events
    Filipino Patients With Hypercholesterolemia
    Affected / at Risk (%) # Events
    Total 0/4748 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

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

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00909389
    Other Study ID Numbers:
    • P05647
    First Posted:
    May 28, 2009
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022