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Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

Primary Purpose

Hypercholesterolemia, Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe
Placebo
Atorvastatin 10 mg
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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation. Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL). Participants must have two or more coronary heart disease risk factors listed below: Current cigarette smoking Hypertension (BP >= 140/90 mmHg or on antihypertensive medication) Low HDL cholesterol (< 40 mg/dL) Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years) Age (Men >= 45 years; women >= 55 years) Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating. Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal. Participants must have maintained a cholesterol lowering diet, exercise program, and stable weight for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study. Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study. Exclusion Criteria: Participants who meet any of the following criteria will be excluded: Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2. Consume > 14 alcoholic drinks per week. Women who are pregnant or nursing. Congestive heart failure defined by NYHA as Class III or IV. Uncontrolled cardiac arrhythmia. Coronary heart disease (CHD). Unstable or severe peripheral artery disease within 3 months of participating Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg. Type I or Type II diabetes mellitus. Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism. Impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome. Known HIV positive. Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas). History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. Participants who are on any of the following concomitant medications: Participants who are on medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (> 1 quart/day). Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day) Participants who are on over the counter lipid lowering agents such as fish oils, garlic and cholestin Participants who are on oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks. Participants who are currently using psyllium, other fiber-based laxatives, and/or any other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks and who do not agree to remain on this regimen throughout the study. Participant who are currently using orlistat or sibutramine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ezetimibe 10 mg

    Placebo 10 mg

    Arm Description

    Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

    Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

    Outcomes

    Primary Outcome Measures

    Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
    12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.

    Secondary Outcome Measures

    Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
    12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.
    High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
    12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.

    Full Information

    First Posted
    April 28, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    PT. Schering-Plough. Tbk Indonesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00319449
    Brief Title
    Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
    Official Title
    A Single Center, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 Mg In Subjects With Primary Hypercholesterolemia And Multiple Coronary Heart Disease Risk Factors in Indonesian Population.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    PT. Schering-Plough. Tbk Indonesia

    4. Oversight

    5. Study Description

    Brief Summary
    This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ezetimibe 10 mg
    Arm Type
    Experimental
    Arm Description
    Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
    Arm Title
    Placebo 10 mg
    Arm Type
    Placebo Comparator
    Arm Description
    Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe
    Intervention Description
    10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin 10 mg
    Intervention Description
    10 mg/day atorvastatin, orally, (ongoing treatment in participants)
    Primary Outcome Measure Information:
    Title
    Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
    Description
    12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.
    Time Frame
    Baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
    Description
    12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.
    Time Frame
    6 weeks post treatment
    Title
    High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
    Description
    12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.
    Time Frame
    6 weeks post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation. Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL). Participants must have two or more coronary heart disease risk factors listed below: Current cigarette smoking Hypertension (BP >= 140/90 mmHg or on antihypertensive medication) Low HDL cholesterol (< 40 mg/dL) Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years) Age (Men >= 45 years; women >= 55 years) Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating. Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal. Participants must have maintained a cholesterol lowering diet, exercise program, and stable weight for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study. Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study. Exclusion Criteria: Participants who meet any of the following criteria will be excluded: Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2. Consume > 14 alcoholic drinks per week. Women who are pregnant or nursing. Congestive heart failure defined by NYHA as Class III or IV. Uncontrolled cardiac arrhythmia. Coronary heart disease (CHD). Unstable or severe peripheral artery disease within 3 months of participating Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg. Type I or Type II diabetes mellitus. Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism. Impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome. Known HIV positive. Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas). History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. Participants who are on any of the following concomitant medications: Participants who are on medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (> 1 quart/day). Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day) Participants who are on over the counter lipid lowering agents such as fish oils, garlic and cholestin Participants who are on oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks. Participants who are currently using psyllium, other fiber-based laxatives, and/or any other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks and who do not agree to remain on this regimen throughout the study. Participant who are currently using orlistat or sibutramine.

    12. IPD Sharing Statement

    Learn more about this trial

    Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

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