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Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ezetimibe
Simvastatin
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with hypercholesterolemia who satisfy the following criteria:

    • Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below
    • Age: 20 years of age or older (at the time of obtaining informed consent)
    • Sex: both males and females
    • Inpatient/outpatient: Out-patients

Exclusion Criteria:

  • Patients for whom any of the following is applicable:

    • Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
    • Patients with homozygous familial hypercholesterolemia
    • Patients with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
    • Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
    • Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets
    • Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study.
    • Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
    • Patients who are using cyclosporine from after the start of the observation period
    • Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate
    • Patients with a history of ezetimibe use

    • Patients with hyperlipidemia associated with the following diseases:

      • Hypothyroidism
      • Obstructive gall bladder or biliary disease
      • Chronic renal failure
      • Pancreatitis
    • Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
    • Patients who have received an investigational drug within 4 weeks of the start of the observation period
    • Other patients deemed not appropriate for study entry by the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ezetimibe + Simvastatin

    Arm Description

    Ezetimibe 10 mg + Simvastatin 20 mg

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events and Adverse Reactions
    An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was treatment-related was considered an adverse reaction.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00653523
    Brief Title
    Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
    Official Title
    Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2007 (Actual)
    Primary Completion Date
    June 1, 2009 (Actual)
    Study Completion Date
    June 1, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ezetimibe + Simvastatin
    Arm Type
    Experimental
    Arm Description
    Ezetimibe 10 mg + Simvastatin 20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe
    Other Intervention Name(s)
    SCH 58235
    Intervention Description
    Ezetimibe 10 mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Intervention Description
    Simvastatin 20 mg daily
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events and Adverse Reactions
    Description
    An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was treatment-related was considered an adverse reaction.
    Time Frame
    Throughout 1 year of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with hypercholesterolemia who satisfy the following criteria: Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below Age: 20 years of age or older (at the time of obtaining informed consent) Sex: both males and females Inpatient/outpatient: Out-patients Exclusion Criteria: Patients for whom any of the following is applicable: Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL Patients with homozygous familial hypercholesterolemia Patients with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period. Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period. Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study. Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.) Patients who are using cyclosporine from after the start of the observation period Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate Patients with a history of ezetimibe use Patients with hyperlipidemia associated with the following diseases: Hypothyroidism Obstructive gall bladder or biliary disease Chronic renal failure Pancreatitis Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc Patients who have received an investigational drug within 4 weeks of the start of the observation period Other patients deemed not appropriate for study entry by the investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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    Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

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