Phase 3 N=1,220 Randomized Double-blind Treatment

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

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00271817 ↗

Enrolled (actual)

1,220

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) — -20.1; -58.5 Percent change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: ezetimibe/simvastatin + niacin (ER) (Drug); Comparator: Placebo to ezetimibe/simvastatin (Drug); Comparator: niacin (ER) tablet (Drug); Comparator: ezetimibe (+) simvastatin (Drug); Comparator: Placebo to Niacin (ER) (Drug); Comparator: ezetimibe/simvastatin and niacin (ER) (Drug); Comparator: ezetimibe and simvastatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	-53.5; -58.5	<0.001 sig
PRIMARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	-53.5; -58.5	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	-47.9; -55.6	<0.001 sig
SECONDARY Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)	9.0; 30.5	<0.001 sig
SECONDARY Percent Change From Baseline in Triglycerides (TG)	-26.8; -44.5	<0.001 sig
SECONDARY Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)	9.0; 30.5	<0.001 sig
SECONDARY Percent Change From Baseline in Triglycerides (TG)	-26.8; -44.5	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	-47.9; -55.6	<0.001 sig
SECONDARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	-53.5; -58.5	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	-47.9; -55.6	<0.001 sig

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00271817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.