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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia

Intervention: 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); Comparator: Placebo to niacin (ER) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

Percent Change From Baseline in Triglycerides (TG)

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

Percent Change From Baseline in Triglycerides (TG)

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: December 2005
Last updated: October 31, 2014

Page last updated: August 23, 2015

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