To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

Phase 3CompletedNCT00271817

Organon and Co1,220 enrolled

Overview

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,220

Conditions

Hypercholesterolemia

Interventions

Comparator: ezetimibe/simvastatin + niacin (ER)DRUG

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Comparator: Placebo to ezetimibe/simvastatinDRUG

ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.

Comparator: niacin (ER) tabletDRUG

niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL * Patient willing to be on a low-cholesterol diet Exclusion Criteria: * Pregnant or lactating women or intending to become pregnant * Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet * Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin * Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Outcomes

Primary Outcomes

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline

Time frame: Baseline and 24 Weeks

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline

Time frame: Baseline and 24 weeks

Secondary Outcomes

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline

Time frame: Baseline and 24 weeks

Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline

Time frame: Baseline and 24 weeks

Percent Change From Baseline in Triglycerides (TG)

Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline

Time frame: baseline and 24 Weeks

Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

Data from ClinicalTrials.gov

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