| January 3, 2006 |
| November 6, 2009 |
| December 2005 |
| September 2007 (final data collection date for primary outcome measure) |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ] |
| Change in non-HDL-C |
| Complete list of historical versions of study NCT00271817 on ClinicalTrials.gov Archive Site |
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline and 24 Weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
|
| Change in other lipid variables |
| |
| To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia |
| 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 |
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Hypercholesterolemia |
- Drug: 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)
|
- Active Comparator: ezetimibe/simvastatin combination tablet + niacin (ER)
- Active Comparator: ezetimibe/simvastatin
- Active Comparator: Niacin (ER)
- Placebo Comparator: ezetimibe/simvastatin combination tablet + niacin (Pbo)
|
| 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. |
| |
| Completed |
| 1220 |
| February 2008 |
| September 2007 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 79 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00271817 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2005_091, MK0653A-091 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| November 2009 |
