A Multi-Risk Factor Strategy vs a Guideline-Based Approac... | NCT00412113

Label	Type	Description	Intervention Names
Norvasc 5 mg	Active Comparator	Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate
Caduet 10/20mg	Experimental	Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.	Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Norvasc 10 mg	Active Comparator	Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate
Caduet 5/20mg	Experimental	Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .	Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine besylate	Drug	Amlodipine besylate 5 mg	Norvasc 5 mg
Amlodipine besylate/atorvastatin calcium single pill combination

Measure	Description	Time Frame
Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6	Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)	Week 6
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk	Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.	Week 6, baseline

Measure	Description	Time Frame
Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4	Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35209	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
FG001	Caduet + TLC

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

Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)

Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000115 OG001118

Title

Denominators

Categories

Title	Measurements
	OG00011 OG00180

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	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(< 140/90 mmHg) and LDL goal (< 100mg/dL) at Week 6. With ~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP <140/90 mmHg and LDL <100 mg/dL and using a chi-square test with 0.05 two-sided significance level.	Cochran-Mantel-Haenszel		<0.001	There was only one primary endpoint and the p-value was not adjusted for comparison.	Odds Ratio (OR)	19.03				95	9.14	39.63

Secondary

Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.

Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants

Secondary

Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.

Full analysis set (FAS).

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Subjects With LDL-C < 100 mg/dL at Week 4

Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Subjects With LDL-C < 100 mg/dL at Week 6

Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.

Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Subjects With BP < 140/90 mmHg at Week 4

Subjects achieving BP goal of <140/90 mmHg at week 4

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Subjects With BP < 140/90 mmHg at Week 6

Subjects achieving BP goal of <140/90 mmHg at week 6

Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).

Mean at observation minus mean at baseline

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mmHg

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

Mean at observation minus mean at baseline

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mmHg

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 4 in Pulse Rate

Mean at observation minus mean at baseline measured in beats per minute (bpm).

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

bpm

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)

Mean change at observation minus mean baseline.

Full analysis set: all randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Mean

Standard Deviation

mmHg

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

Change from mean at observation minus mean at baseline

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Median

Standard Deviation

mmHg

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 6 in Pulse Rate

Mean at observation minus mean at baseline

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

bpm

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in LDL at Week 4.

Change: mean of observation minus mean at baseline.

Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Mean

Standard Deviation

mg/dL

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in High Density Lipoprotein (HDL) at Week 4.

Mean change at observation minus baseline.

Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Mean

Standard Deviation

mg/dL

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Total Cholesterol (TC) From Baseline to Week 4.

Mean change at observation minus baseline.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mg/dL

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Triglycerides (TG) to Week 4.

Mean change at observation minus baseline

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mg/dL

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in LDL at Week 6.

Mean change at observation minus baseline.

Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mg/dL

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HDL at Week 6.

Mean change at observation minus baseline.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mg/dL

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Cholesterol (TC) to Week 6.

Mean change at observation minus baseline.

Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

Posted

Mean

Standard Deviation

mg/dL

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Triglycerides (TG) at Week 6.

Mean change at observation minus mean baseline.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Mean

Standard Deviation

mg/dL

Week 6 , baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.

Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.

Posted

Least Squares Mean

Standard Deviation

score on scale

Week 4, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Primary

Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment

Posted

Least Squares Mean

Standard Deviation

score on scale

Week 6, baseline

ID	Title	Description
OG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
OG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.			0	122	16	122
EG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.			0	122	7	122

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema peripheral	General disorders	MedDRA v11.1	Systematic Assessment	EG0008 affected122 at risk EG0013 affected122 at risk
Urinary tract infection	Infections and infestations	MedDRA v11.1	Systematic Assessment	EG0003 affected122 at risk EG0011 affected122 at risk
Hypertension	Vascular disorders	MedDRA v11.1	Systematic Assessment	EG0005 affected122 at risk EG0013 affected122 at risk

ID	Term
D050171	Dyslipidemias
D006973	Hypertension

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Norvasc + TLC	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
BG001	Caduet + TLC	Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
BG002	Total	Total of all reporting groups