A Study of Ezetimibe Added On to Rosuvastatin Versus Up T... | NCT00783263

ID	Type	Description	Link
2008_567

A Study of Ezetimibe Added On to Rosuvastatin Versus Up T... | NCT00783263 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rosuvastatin 5 mg + Ezetimibe 10 mg	Experimental	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.	Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg
Rosuvastatin 10 mg	Active Comparator	Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.	Drug: Comparator: rosuvastatin 10 mg
Rosuvastatin 10 mg + Ezetimibe 10 mg	Experimental	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.	Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg
Rosuvastatin 20 mg	Active Comparator	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.	Drug: Comparator: rosuvastatin 20 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparator: rosuvastatin 5 mg + ezetimibe 10 mg	Drug	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment	The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.	Baseline to 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum	The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.	Baseline to 6 weeks

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21596364	Result	Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rosuvastatin 5 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
FG001	Rosuvastatin 10 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0003 subjects FG0010 subjects FG0022 subjects FG0031 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Withdrawal by Subject		FG0000 subjects FG0011 subjects FG0021 subjects FG0032 subjects

Arm/Group Information

ID	Title	Description
BG000	Rosuvastatin 5 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
BG001	Rosuvastatin 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
BG002	Rosuvastatin 10 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
BG003	Rosuvastatin 20 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00099 BG00198 BG002122 BG003121 BG004440

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG00063 BG00162 BG00271 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00140 BG002

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 From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment

The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Posted

Mean

Standard Deviation

percent change

Baseline to 6 weeks

ID	Title	Description
OG000	Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg	Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin (10 or 20 mg)	Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.

Units	Counts
Participants	OG000219 OG001217

Title

Denominators

Categories

Title	Measurements
	OG000-21.57± 25.09 OG001-5.58± 25.42

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		Longitudinal Data Analysis (LDA)	Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.	<0.001		Mean Difference (Final Values)	-15.25			2-Sided	95	-19.89	-10.60					Superiority or Other (legacy)

Secondary

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum

The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Posted

Mean

Standard Deviation

percentage change

Baseline to 6 weeks

ID	Title	Description
OG000	Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin 10 mg (Stratum I)	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
OG002	Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
OG003

Secondary

Number of Participants Who Reached Their Target LDL-C Level

Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.

Posted

Number

participants

6 weeks of treatment

ID	Title	Description
OG000	Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin (10 or 20 mg)	Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each Stratum Who Reached Their Target LDL-C Level

Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.

Posted

Number

participants

6 weeks of treatment

ID	Title	Description
OG000	Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin 10 mg (Stratum I)	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
OG002	Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

Secondary

Number of Participants Who Reached the LDL-C Level of <70 mg/dl

Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Posted

Number

participants

6 weeks of treatment

ID	Title	Description
OG000	Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin 10 or 20 mg	Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl

Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).

Posted

Number

participants

6 weeks of treatment

ID	Title	Description
OG000	Rosuvastatin 5 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
OG002	Rosuvastatin 10 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
OG003	Rosuvastatin 20 mg

Secondary

Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels

Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.

Posted

Mean

Standard Deviation

percentage change

Baseline to 6 weeks

ID	Title	Description
OG000	Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
OG001	Rosuvastatin 10 or 20 mg	Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Rosuva 5 mg + EZ 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.	0	99	99
EG001	Rosuva 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.	1	98	98
EG002	Rosuva 10 mg + EZ 10 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.	0	122	122
EG003	Rosuva 20 mg	Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.	1	121	121

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Sick sinus syndrome	Cardiac disorders	MedDRA 13.0	Systematic Assessment		EG0000 events0 affected99 at risk EG0010 events0 affected98 at risk EG0020 events0 affected122 at risk EG0031 events1 affected121 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment		EG0000 events0 affected99 at risk EG0011 events1 affected98 at risk EG0020 events0 affected122 at risk EG003

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines

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		Longitudinal Data Analysis (LDA)	Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.	<0.001		Mean Difference (Final Values)	-12.31			2-Sided	95	-18.95	-5.67					Superiority or Other (legacy)
OG002 OG003		Longitudinal Data Analysis (LDA)	Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.	<0.001		Mean Difference (Final Values)	-17.46			2-Sided	95	-23.92	-10.99					Superiority or Other (legacy)

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		Logistic Regression	Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: <100, 100-<130, ≥130 mg/dL).	<0.001		Odds Ratio (OR)	4.5			2-Sided	95	2.9	6.9					Superiority or Other (legacy)

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		Logistic Regression	Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: <100, 100-<130, >=130 mg/dL).	<0.001		Odds Ratio (OR)	3.1			2-Sided	95	1.7	5.8					Superiority or Other (legacy)
OG002 OG003		Logistic Regression	Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: <100, 100-<130, >=130 mg/dL).	<0.001		Odds Ratio (OR)	6.5			2-Sided	95	3.4	12.3					Superiority or Other (legacy)

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		Logistic Regression		<0.001		Odds Ratio (OR)	8.0			2-Sided	95	4.6	14.0					Superiority or Other (legacy)

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	Stratum I	Logistic Regression		<0.001		Odds Ratio (OR)	5.1			2-Sided	95	2.2	11.8					Superiority or Other (legacy)
OG002 OG003	Stratum II	Logistic Regression		<0.001		Odds Ratio (OR)	11.4			2-Sided	95	5.2	24.8					Superiority or Other (legacy)

Title

Denominators

Categories

Total Cholesterol (TC)

Title	Measurements
	OG000-13.00± 17.51 OG001-3.76± 14.35

Triglycerides

Title	Measurements
	OG000-5.96± 36.45 OG001-3.60± 32.83

High-Density Lipoprotein Cholesterol

Title	Measurements
	OG000-0.67± 15.51 OG0012.18± 13.38

Non High-Density Liproprotein Cholesterol

Title	Measurements
	OG000-17.59± 23.55 OG001-5.29± 21.20

LDL Cholesterol/HDL Cholesterol

Title	Measurements
	OG000-19.48± 27.63 OG001-6.18± 27.82

Total Cholesterol/HDL Cholesterol

Title	Measurements
	OG000-10.57± 25.87 OG001-4.40± 18.27

Non-HDL Cholestrol/HDL Cholesterol

Title	Measurements
	OG000-14.51± 35.39 OG001-5.31± 26.63

Apolipoprotein B (Apo B)

Title	Measurements
	OG000-14.31± 18.61 OG001-4.25± 17.56

Apolipoprotein A-I (Apo A-I)

Title	Measurements
	OG000-1.44± 12.49 OG0011.06± 11.56

Apolipoprotein B/Apo A-I

Title	Measurements
	OG000-11.98± 20.84 OG001-4.11± 19.61

hs-C-Reactive Protein

Title	Measurements
	OG000-13.98± 72.19 OG001-12.82± 73.08

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Total Cholesterol (mg/dL)	Longitudinal Data Analysis	<0.001	Mean Difference (Final Values)	-8.65	2-Sided	95	-11.59	-5.71	Superiority or Other (legacy)
OG000 OG001	Triglycerides (mg/dL)	Longitudinal Data Analysis	0.306	Mean Difference (Final Values)	-3.10	2-Sided	95	-9.04	2.84	Superiority or Other (legacy)
OG000 OG001	High-Density Lipoprotein Cholesterol	Longitudinal Data Analysis	0.111	Mean Difference (Final Values)	-2.15	2-Sided	95	-4.79	0.49	Superiority or Other (legacy)
OG000 OG001	Non High-Density Liproprotein Cholesterol	Longitudinal Data Analysis	<0.001	Mean Difference (Final Values)	-11.98	2-Sided	95	-16.10	-7.86	Superiority or Other (legacy)
OG000 OG001	LDL Cholesterol/HDL Cholesterol	Longitudinal Data Analysis	<0.001	Mean Difference (Final Values)	-13.25	2-Sided	95	-18.36	-8.13	Superiority or Other (legacy)
OG000 OG001	Total Cholesterol/HDL Cholesterol	Longitudinal Data Analysis	0.002	Mean Difference (Final Values)	-6.45	2-Sided	95	-10.53	-2.36	Superiority or Other (legacy)
OG000 OG001	Non-HDL Cholestrol/HDL Cholesterol	Longitudinal Data Analysis	0.001	Mean Difference (Final Values)	-9.52	2-Sided	95	-15.30	-3.75	Superiority or Other (legacy)
OG000 OG001	Apolipoprotein B (Apo B)	Longitudinal Data Analysis	<0.001	Mean Difference (Final Values)	-9.41	2-Sided	95	-12.74	-6.08	Superiority or Other (legacy)
OG000 OG001	Apolipoprotein A-I (Apo A-I)	Longitudinal Data Analysis	0.102	Mean Difference (Final Values)	-1.82	2-Sided	95	-3.99	0.36	Superiority or Other (legacy)
OG000 OG001	Apolipoprotein B/Apo A-I	Longitudinal Data Analysis	<0.001	Mean Difference (Final Values)	-7.54	2-Sided	95	-11.25	-3.83	Superiority or Other (legacy)
OG000 OG001	hs-C-Reactive Protein	Longitudinal Data Analysis	0.861	Mean Difference (Final Values)	-1.08	2-Sided	95	-13.13	10.97	Superiority or Other (legacy)

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases