| January 3, 2006 |
| April 3, 2013 |
| December 2005 |
| February 2008 (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 ]
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
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
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
|
| 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 ]
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
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline and 24 Weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
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
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
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
|
| Change in other lipid variables |
| Not Provided |
| Not Provided |
| |
| To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment |
| Hypercholesterolemia |
- 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
- Drug: Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
- Drug: Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
- Drug: Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
- Drug: Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
- Drug: 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
- Drug: Comparator: ezetimibe and simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
- Drug: Comparator: Placebo to niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
|
- Active Comparator: Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Intervention: Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
- Active Comparator: Part 1 -Arm 2
ezetimibe/simvastatin
Interventions:
- Drug: Comparator: ezetimibe (+) simvastatin
- Drug: Comparator: Placebo to Niacin (ER)
- Active Comparator: Part 1 - Arm 3
Niacin (ER)
Interventions:
- Drug: Comparator: Placebo to ezetimibe/simvastatin
- Drug: Comparator: niacin (ER) tablet
- Active Comparator: Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Intervention: Drug: Comparator: ezetimibe/simvastatin and niacin (ER)
- Placebo Comparator: Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
Interventions:
- Drug: Comparator: ezetimibe and simvastatin
- Drug: Comparator: Placebo to niacin (ER)
|
- 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.
- Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. Epub 2012 Feb 14.
|
| |
| Completed |
| 1220 |
| February 2008 |
| February 2008 (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 |
| Not Provided
| |
| NCT00271817 |
| 2005_091, MK0653A-091 |
| Not Provided
| Merck |
| Merck |
| Not Provided
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| April 2013 |
