An Open-Label Study to Compare the Lipid Effects of Niaci... | NCT00465088

ID	Type	Description	Link
M10-013

Label	Type	Description	Intervention Names
1	Experimental		Drug: Niacin ER/Simvastatin Tablets
2	Experimental		Drug: atorvastatin

Name	Type	Description	Arm Group Labels	Other Names
Niacin ER/Simvastatin Tablets	Drug	Up to 2000 mg/40 mg at bedtime	1

Measure	Description	Time Frame
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12	(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C	From baseline to Week 12

Measure	Description	Time Frame
Percent Change in HDL-C From Baseline to Week 8	(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C	From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8	(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

Name	Affiliation	Role
Roopal Thakkar, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Anaheim	California	92801	United States

ID	Title	Description
FG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
FG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG00082 OG00170

Title

Denominators

Categories

Title	Measurements
	OG00030.1(25.6 to 34.6) OG0019.4(4.3 to 14.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide > 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%	Mixed Models Analysis		<0.001	alpha = 0.05						95						No	Superiority or Other

Secondary

Percent Change in HDL-C From Baseline to Week 8

(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

All treated subjects whose Week 8 value was obtained within the Week 8 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 8

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Non-HDL-C From Baseline to Week 8

(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

All treated subjects whose Week 8 value was obtained within the Week 8 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 8

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Non-HDL-C From Baseline to Week 12

(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12

(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Triglycerides From Baseline to Week 12

(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Posted

Median

Inter-Quartile Range

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in LDL-C:HDL-C Ratio

(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

All treated subjects whose Week 12 values were obtained within the Week 12 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Cholesterol From Baseline to Week 12

(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Cholesterol:HDL-C Ratio

(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

All treated subjects whose Week 12 values were obtained within the Week 12 visit window

Posted

Least Squares Mean

95% Confidence Interval

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percent Change in Lipoprotein A From Baseline to Week 12

(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Posted

Median

Inter-Quartile Range

percent change

From baseline to Week 12

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12

All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value

Posted

Number

Percentage of subjects

12 weeks

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12

For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value

Posted

Number

Percentage of subjects

12 weeks

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value

Posted

Number

Percentage of subjects

12 weeks

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12

NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters

Posted

Number

Percentage of subjects

12 weeks

ID	Title	Description
OG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
OG001	Atorvastatin	40 mg atorvastatin once daily at bedtime

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0005 affected114 at risk EG0010 affected79 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 affected114 at risk EG0012 affected79 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 affected114 at risk EG0010 affected79 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG00011 affected114 at risk EG0010 affected79 at risk
Edema peripheral	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Nasopharyngitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0002 affected114 at risk EG0012 affected79 at risk
Tooth infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0003 affected114 at risk EG0010 affected79 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Blood creatinine phosphokinase increased	Investigations	MedDRA 9.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected79 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 affected114 at risk EG0012 affected79 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 affected114 at risk EG0014 affected79 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 affected114 at risk EG0011 affected79 at risk
Dizziness	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 affected114 at risk EG0012 affected79 at risk
Headache	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 affected114 at risk EG0012 affected79 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 affected114 at risk EG0012 affected79 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0007 affected114 at risk EG0010 affected79 at risk
Flushing	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG00077 affected114 at risk EG0018 affected79 at risk

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description
BG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
BG001	Atorvastatin	40 mg atorvastatin once daily at bedtime
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Niacin Extended-release Plus Simvastatin	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime			2		89
EG001	Atorvastatin	40 mg atorvastatin once daily at bedtime			1		27

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment		EG0001 affected114 at risk EG0010 affected79 at risk
Chest pain	General disorders	MedDRA 9.1	Non-systematic Assessment		EG0001 affected114 at risk EG0011 affected79 at risk