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

This study has been completed.

Study NCT00271817 Information provided by Merck

First Received: January 3, 2006 Last Updated: November 6, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition:	Hypercholesterolemia
Interventions:	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)

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Niacin	(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
Ezetimibe/Simvastatin	(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
Ezetimibe/Simvastatin + Niacin	(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.

Description

Niacin

(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.

Ezetimibe/Simvastatin

(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.

(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.

Ezetimibe/Simvastatin + Niacin

(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.

(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.

Baseline Measures

	Niacin	Ezetimibe/Simvastatin	Ezetimibe/Simvastatin + Niacin	Total
Number of Participants [units: participants]	272	272	676	1220
Age [units: years] Mean ± Standard Deviation	56.4 ± 10.6	57.5 ± 10.3	56.9 ± 10.9	56.9 ± 10.7
Gender [units: participants]
Female	136	120	352	608
Male	136	152	324	612
Race/Ethnicity, Customized [units: participants]
Asian	11	4	11	26
Black	13	17	38	68
Hispanic	14	11	49	74
Other	3	0	2	5
White	231	240	576	1047
Body Mass Index [units: Participants]
<25 kg/m2	48	39	135	222
25 to <30 kg/m2	110	119	252	481
30 to <40 kg/m2	97	94	251	442
≥ 40 kg/m2	16	19	34	69
No BMI Data	1	1	4	6

Outcome Measures

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1. Primary:

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Baseline and 24 Weeks ]

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2. Primary:

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Baseline and 24 weeks ]

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3. Secondary:

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Baseline and 24 weeks ]

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4. Secondary:

Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Baseline and 24 weeks ]

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5. Secondary:

Percent Change From Baseline in Triglycerides (TG) [ baseline and 24 Weeks ]

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6. Secondary:

Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Baseline and 64 weeks ]

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7. Secondary:

Percent Change From Baseline in Triglycerides (TG) [ Baseline and 64 weeks ]

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8. Secondary:

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Baseline and 64 weeks ]

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9. Secondary:

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Baseline and 64 weeks ]

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10. Secondary:

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Baseline and 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Part 1 population is all patients enrolled in Part 1 of the study. Part 2 is those patients who received either niacin, ezetimibe/simvastatin, or ezetimibe/simvastatin + niacin during Part 1 until they finished the study at week 64 or discontinued.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_091, MK0653A-091
Study First Received:	January 3, 2006
Results First Received:	February 13, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00271817 History of Changes
Health Authority:	United States: Food and Drug Administration