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

Hypercholesterolemia Clinical Trial

Official title:

Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271817
• Other study ID #: 0653A-091
• Secondary ID: 2005_091
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: February 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Comparator: ezetimibe/simvastatin + niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
• Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
• Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
• Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
• Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
• Comparator: ezetimibe/simvastatin and niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
• Comparator: ezetimibe and simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
• Comparator: Placebo to niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 24 Weeks
Primary	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	Baseline and 24 weeks
Secondary	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	Baseline and 24 weeks
Secondary	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	Baseline and 24 weeks
Secondary	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	baseline and 24 Weeks
Secondary	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 64 weeks - 64 week measure minus baseline	Baseline and 64 weeks
Secondary	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 64 weeks - 64 week measure minus baseline	Baseline and 64 weeks
Secondary	Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline	Baseline and 64 weeks
Secondary	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 64 weeks - 64 week measure minus baseline	Baseline and 64 weeks
Secondary	Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline	Baseline and 24 weeks