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Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

Primary Purpose

Hypercholesterolemia, Atherosclerosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ezetimibe

Placebo

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:

>=18 years and <= 75 years of age with LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit
documented coronary heart disease
currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3
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 at Baseline Visit.
cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history.
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 continue same regimen during the study.
women of non-childbearing potential or using acceptable method of birth control.
subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.

Exclusion Criteria:

Subjects whose body mass index is >=30 kg/sqm at baseline.
Subjects who consume >14 alcoholic drinks per week.
Any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
Women who are pregnant or nursing.
Subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ezetimibe

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline to end of treatment in LDL-C.

Secondary Outcome Measures

Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines.

Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides.

Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations.

Full Information

NCT ID

NCT00651404

First Posted

March 31, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00651404

Brief Title

Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

Official Title

A Multicenter, 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 Coronary Heart Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.

6. Conditions and Keywords

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

Hypercholesterolemia, Atherosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ezetimibe

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ezetimibe

Other Intervention Name(s)

SCH 058235, Zetia

Intervention Description

oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)

Primary Outcome Measure Information:

Title

Percent change from baseline to end of treatment in LDL-C.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines.

Time Frame

6 weeks

Title

Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides.

Time Frame

6 weeks

Title

Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations.

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >=18 years and <= 75 years of age with LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit documented coronary heart disease currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3 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 at Baseline Visit. cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history. 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 continue same regimen during the study. women of non-childbearing potential or using acceptable method of birth control. subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations. Exclusion Criteria: Subjects whose body mass index is >=30 kg/sqm at baseline. Subjects who consume >14 alcoholic drinks per week. Any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study. Women who are pregnant or nursing. Subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.

12. IPD Sharing Statement

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Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

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