TOGETHER: A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00412113
• Collaborator: (none)
• Enrollment: 245
• Locations: 51
• Arms: 4
• Duration (Months): 15
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia; Hypertension	Drug: Amlodipine besylate; Drug: Amlodipine besylate/atorvastatin calcium single pill combination; Drug: Amlodipine besylate; Drug: Amlodipine besylate/atorvastatin calcium single pill combination	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Norvasc 5 mg Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate; Amlodipine besylate 5 mg
Experimental: Caduet 10/20mg 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; Amlodipine/atorvastatin single pill combination 10/20 mg
Active Comparator: Norvasc 10 mg Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate; Amlodipine besylate 10 mg
Experimental: Caduet 5/20mg 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; Amlodipine/atorvastatin single pill combination 5/20 mg

Outcome Measures

Primary Outcome Measures

1. 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 [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)

2. Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk [Week 6, baseline]

   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.

Secondary Outcome Measures

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

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

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

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

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

5. Subjects With LDL-C < 100 mg/dL at Week 6 [Week 6]

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

6. Subjects With BP < 140/90 mmHg at Week 4 [Week 4]

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

7. Subjects With BP < 140/90 mmHg at Week 6 [Week 6]

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

8. Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). [Week 4, baseline]

   Mean at observation minus mean at baseline

9. Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) [Week 4, baseline]

   Mean at observation minus mean at baseline

10. Change From Baseline to Week 4 in Pulse Rate [Week 4, baseline]

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

11. Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) [Week 6, baseline]

    Mean change at observation minus mean baseline.

12. Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) [Week 6, baseline]

    Change from mean at observation minus mean at baseline

13. Change From Baseline to Week 6 in Pulse Rate [Week 6, baseline]

    Mean at observation minus mean at baseline

14. Change From Baseline in LDL at Week 4. [Week 4, baseline]

    Change: mean of observation minus mean at baseline.

15. Change From Baseline in High Density Lipoprotein (HDL) at Week 4. [Week 4, baseline]

    Mean change at observation minus baseline.

16. Change in Total Cholesterol (TC) From Baseline to Week 4. [Week 4, baseline]

    Mean change at observation minus baseline.

17. Change From Baseline in Triglycerides (TG) to Week 4. [Week 4, baseline]

    Mean change at observation minus baseline

18. Change From Baseline in LDL at Week 6. [Week 6, baseline]

    Mean change at observation minus baseline.

19. Change From Baseline in HDL at Week 6. [Week 6, baseline]

    Mean change at observation minus baseline.

20. Change From Baseline in Total Cholesterol (TC) to Week 6. [Week 6, baseline]

    Mean change at observation minus baseline.

21. Change From Baseline in Triglycerides (TG) at Week 6. [Week 6 , baseline]

    Mean change at observation minus mean baseline.

22. Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk. [Week 4, baseline]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion Criteria:

• Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)

• Subjects that have not been on a stable dose of Norvasc for at least 4 weeks

• Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35209
2	Pfizer Investigational Site	Birmingham	Alabama	United States	35216
3	Pfizer Investigational Site	Birmingham	Alabama	United States	35234
4	Pfizer Investigational Site	Mesa	Arizona	United States	85206
5	Pfizer Investigational Site	Garden Grove	California	United States	92843
6	Pfizer Investigational Site	Mission Viejo	California	United States	92692
7	Pfizer Investigational Site	Rancho Santa Margarita	California	United States	92688
8	Pfizer Investigational Site	Torrance	California	United States	90502
9	Pfizer Investigational Site	Gainesville	Florida	United States	32605
10	Pfizer Investigational Site	Kissimmee	Florida	United States	34741
11	Pfizer Investigational Site	Melbourne	Florida	United States	32935
12	Pfizer Investigational Site	Miami	Florida	United States	33176
13	Pfizer Investigational Site	Safety Harbor	Florida	United States	34695
14	Pfizer Investigational Site	Saint Petersburg	Florida	United States	33701
15	Pfizer Investigational Site	Augusta	Georgia	United States	30904
16	Pfizer Investigational Site	Tucker	Georgia	United States	30084
17	Pfizer Investigational Site	South Bend	Indiana	United States	46601
18	Pfizer Investigational Site	Erlanger	Kentucky	United States	41018
19	Pfizer Investigational Site	Auburn	Maine	United States	04210
20	Pfizer Investigational Site	Warren	Michigan	United States	48091
21	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55404
22	Pfizer Investigational Site	Chesterfield	Missouri	United States	63017
23	Pfizer Investigational Site	Florissant	Missouri	United States	63031
24	Pfizer Investigational Site	Omaha	Nebraska	United States	68116-2004
25	Pfizer Investigational Site	Henderson	Nevada	United States	89014
26	Pfizer Investigational Site	Henderson	Nevada	United States	89015
27	Pfizer Investigational Site	Belvidere	New Jersey	United States	07823
28	Pfizer Investigational Site	Bridgewater	New Jersey	United States	08807
29	Pfizer Investigational Site	Clifton	New Jersey	United States	07013
30	Pfizer Investigational Site	Elizabeth	New Jersey	United States	07202
31	Pfizer Investigational Site	Hillsborough	New Jersey	United States	08844
32	Pfizer Investigational Site	Trenton	New Jersey	United States	08618
33	Pfizer Investigational Site	Brooklyn	New York	United States	11229
34	Pfizer Investigational Site	Buffalo	New York	United States	14209
35	Pfizer Investigational Site	Cincinnati	Ohio	United States	45219
36	Pfizer Investigational Site	Cincinnati	Ohio	United States	45242
37	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73103
38	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74136
39	Pfizer Investigational Site	Bensalem	Pennsylvania	United States	19020
40	Pfizer Investigational Site	Lansdale	Pennsylvania	United States	19446
41	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19146
42	Pfizer Investigational Site	Providence	Rhode Island	United States	02904
43	Pfizer Investigational Site	Goose Creek	South Carolina	United States	29445
44	Pfizer Investigational Site	Mount Pleasant	South Carolina	United States	29464
45	Pfizer Investigational Site	Bristol	Tennessee	United States	37620
46	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
47	Pfizer Investigational Site	Dallas	Texas	United States	75235
48	Pfizer Investigational Site	Houston	Texas	United States	77030-2324
49	Pfizer Investigational Site	Plano	Texas	United States	75093
50	Pfizer Investigational Site	San Antonio	Texas	United States	78238
51	Pfizer Investigational Site	Chesapeake	Virginia	United States	23320

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00412113
• Other Study ID Numbers: A3841045
• First Posted: Dec 15, 2006
• Last Update Posted: Feb 11, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Dyslipidemias; Calcium, Dietary; Amlodipine; Atorvastatin; Calcium

Study Results

Participant Flow

Pre-assignment Detail	The study enrolled 244 evaluable subjects. Drug treatments were used prior to the start of the study in all subjects in the Caduet and therapeutic lifestyle changes (TLC) group and the Norvasc and TLC group. Amlodipine was used by all subjects prior to entry. The study's four arms are two groups, each with drug group and matching placebo.

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Period Title: Overall Study
STARTED	123	122
Received Treatment	122	122
COMPLETED	111	107
NOT COMPLETED	12	15

Baseline Characteristics

Arm/Group Title	Norvasc + TLC	Caduet + TLC	Total
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.	Total of all reporting groups
Overall Participants	122	122	244
Age, Customized (participants) [Number]
18 to 64 years	95 77.9%	97 79.5%	192 78.7%
> or = to 65 years	27 22.1%	25 20.5%	52 21.3%
Sex: Female, Male (Count of Participants)
Female	56 45.9%	65 53.3%	121 49.6%
Male	66 54.1%	57 46.7%	123 50.4%

Outcome Measures

1. Primary Outcome

Title	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
Description	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)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	11 9%	80 65.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	There was only one primary endpoint and the p-value was not adjusted for comparison.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	19.03
	Confidence Interval	() 95%; 9.14 to 39.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	116
Number [participants]	6 4.9%	73 59.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<100 mg/dL) at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analysis
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	31.39
	Confidence Interval	() 95%; 12.61 to 78.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	41 33.6%	85 69.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<130mg/dL) at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.2
	Confidence Interval	() 95%; 2.93 to 9.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS).

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	45 36.9%	90 73.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<130mg/dL) at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.14
	Confidence Interval	() 95%; 2.89 to 9.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Subjects With LDL-C < 100 mg/dL at Week 4
Description	Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	8 6.6%	96 78.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (<100mg/DL) at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	65.51
	Confidence Interval	() 95%; 27.10 to 158.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Subjects With LDL-C < 100 mg/dL at Week 6
Description	Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	13 10.7%	99 81.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (<100mg/DL) at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	42.04
	Confidence Interval	() 95%; 19.42 to 90.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Subjects With BP < 140/90 mmHg at Week 4
Description	Subjects achieving BP goal of <140/90 mmHg at week 4
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	117
Number [participants]	84 68.9%	87 71.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (< 140/90 mmHg)at Week 4
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.785
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.09
	Confidence Interval	() 95%; 0.60 to 1.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Subjects With BP < 140/90 mmHg at Week 6
Description	Subjects achieving BP goal of <140/90 mmHg at week 6
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Number [participants]	83 68%	94 77%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (< 140/90 mmHg) at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.171
	Comments	No adjustment for p-value for secondary analyses
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.55
	Confidence Interval	() 95%; 0.83 to 2.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
Description	Mean at observation minus mean at baseline
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mmHg]	-2.6 (12.1)	-1.5 (11.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.585
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.76
	Confidence Interval	() 95%; -1.97 to 3.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Description	Mean at observation minus mean at baseline
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mmHg]	-1.5 (7.7)	-1.2 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	> 0.999
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.00
	Confidence Interval	() 95%; -2.01 to 2.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline to Week 4 in Pulse Rate
Description	Mean at observation minus mean at baseline measured in beats per minute (bpm).
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [bpm]	-0.1 (8.2)	-0.9 (8.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.363
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.90
	Confidence Interval	() 95%; -2.83 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
Description	Mean change at observation minus mean baseline.
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mmHg]	-1.0 (12.6)	-4.0 (11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS means
	Estimated Value	-3.25
	Confidence Interval	() 95%; -5.99 to -0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
Description	Change from mean at observation minus mean at baseline
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Median (Standard Deviation) [mmHg]	-1.1 (7.1)	-1.7 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.351
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.87
	Confidence Interval	() 95%; -2.71 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline to Week 6 in Pulse Rate
Description	Mean at observation minus mean at baseline
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [bpm]	0.9 (8.1)	1.1 (9.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.922
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.10
	Confidence Interval	() 95%; -1.91 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline in LDL at Week 4.
Description	Change: mean of observation minus mean at baseline.
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	-0.5 (23.0)	-47.8 (24.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-49.30
	Confidence Interval	() 95%; -54.68 to -43.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Description	Mean change at observation minus baseline.
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	0.6 (5.8)	0.6 (8.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.739
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	difference in LS Means
	Estimated Value	-0.30
	Confidence Interval	() 95%; -2.07 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Change in Total Cholesterol (TC) From Baseline to Week 4.
Description	Mean change at observation minus baseline.
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	0.5 (23.5)	-55.9 (26.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-57.9
	Confidence Interval	() 95%; -64.02 to 51.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in Triglycerides (TG) to Week 4.
Description	Mean change at observation minus baseline
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	2.4 (73.2)	-45.7 (62.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-47.27
	Confidence Interval	() 95%; -63.37 to -31.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Change From Baseline in LDL at Week 6.
Description	Mean change at observation minus baseline.
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	0.3 (24.8)	-49.2 (24.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-51.21
	Confidence Interval	() 95%; -56.88 to -45.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline in HDL at Week 6.
Description	Mean change at observation minus baseline.
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	1.2 (8.2)	0.4 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.329
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-1.02
	Confidence Interval	() 95%; -3.07 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Change From Baseline in Total Cholesterol (TC) to Week 6.
Description	Mean change at observation minus baseline.
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	3.7 (23.8)	-56.8 (28.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-62.07
	Confidence Interval	() 95%; -68.49 to -55.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Change From Baseline in Triglycerides (TG) at Week 6.
Description	Mean change at observation minus mean baseline.
Time Frame	Week 6 , baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Mean (Standard Deviation) [mg/dL]	11.6 (115.3)	-42.6 (67.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-53.95
	Confidence Interval	() 95%; -77.61 to -30.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
Description	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.
Time Frame	Week 4, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Least Squares Mean (Standard Deviation) [score on scale]	-0.3 (2.5)	-2.8 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-2.4
	Confidence Interval	() 95%; -3.1 to -1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Primary Outcome

Title	Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
Description	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.
Time Frame	Week 6, baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Norvasc + TLC	Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	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.
Measure Participants	115	118
Least Squares Mean (Standard Deviation) [score on scale]	-0.1 (2.9)	-2.9 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Norvasc + TLC, Caduet + TLC
	Comments	Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	No adjustment for p-value for secondary analyses
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-2.8
	Confidence Interval	() 95%; -3.5 to -2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Norvasc + TLC		Caduet + TLC
Arm/Group Description	Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.		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.
All Cause Mortality
	Norvasc + TLC		Caduet + TLC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Norvasc + TLC		Caduet + TLC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/122 (0%)
Other (Not Including Serious) Adverse Events
	Norvasc + TLC		Caduet + TLC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/122 (13.1%)		7/122 (5.7%)
General disorders
Oedema peripheral	8/122 (6.6%)		3/122 (2.5%)
Infections and infestations
Urinary tract infection	3/122 (2.5%)		1/122 (0.8%)
Vascular disorders
Hypertension	5/122 (4.1%)		3/122 (2.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.