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

NCT00651404 | Completed Phase 3

• 1 other identifier: P03406
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (3)

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

  6 weeks

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

  6 weeks

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

  Throughout study

Study Arms (2)

Ezetimibe

EXPERIMENTAL

Drug: Ezetimibe

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ezetimibe DRUG

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

Also known as: SCH 058235, Zetia

Ezetimibe

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: January 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 17, 2022

Record last verified: 2022-02