Trial Outcomes & Findings for A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk (NCT NCT00412113)

NCT ID: NCT00412113

Last Updated: 2021-02-11

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 245 participants
• Primary outcome timeframe: Week 6
• Results posted on: 2021-02-11

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	123	122
Overall Study Received Treatment	122	122
Overall Study COMPLETED	111	107
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	11	15
Overall Study did not receive treatment	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Norvasc + TLC n=122 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=122 Participants 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 n=244 Participants Total of all reporting groups
Age, Customized 18 to 64 years	95 participants n=5 Participants	97 participants n=7 Participants	192 participants n=5 Participants
Age, Customized > or = to 65 years	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	65 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	57 Participants n=7 Participants	123 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: 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.

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)

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
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	11 participants	80 participants

PRIMARY outcome

Timeframe: Week 6, baseline

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

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.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk	-0.1 score on scale Standard Deviation 2.9	-2.9 score on scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Week 4

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

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.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=116 Participants 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.
Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4	6 participants	73 participants

SECONDARY outcome

Timeframe: Week 4

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

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.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.	41 participants	85 participants

SECONDARY outcome

Timeframe: Week 6

Population: Full analysis set (FAS).

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.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.	45 participants	90 participants

SECONDARY outcome

Timeframe: Week 4

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

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

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Subjects With LDL-C < 100 mg/dL at Week 4	8 participants	96 participants

SECONDARY outcome

Timeframe: Week 6

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

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

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Subjects With LDL-C < 100 mg/dL at Week 6	13 participants	99 participants

SECONDARY outcome

Timeframe: Week 4

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

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

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=117 Participants 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.
Subjects With BP < 140/90 mmHg at Week 4	84 participants	87 participants

SECONDARY outcome

Timeframe: Week 6

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

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

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Subjects With BP < 140/90 mmHg at Week 6	83 participants	94 participants

SECONDARY outcome

Timeframe: Week 4, baseline

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

Mean at observation minus mean at baseline

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).	-2.6 mmHg Standard Deviation 12.1	-1.5 mmHg Standard Deviation 11.9

SECONDARY outcome

Timeframe: Week 4, baseline

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

Mean at observation minus mean at baseline

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)	-1.5 mmHg Standard Deviation 7.7	-1.2 mmHg Standard Deviation 8.8

SECONDARY outcome

Timeframe: Week 4, baseline

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

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

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 4 in Pulse Rate	-0.1 bpm Standard Deviation 8.2	-0.9 bpm Standard Deviation 8.5

SECONDARY outcome

Timeframe: Week 6, baseline

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

Mean change at observation minus mean baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)	-1.0 mmHg Standard Deviation 12.6	-4.0 mmHg Standard Deviation 11.0

SECONDARY outcome

Timeframe: Week 6, baseline

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

Change from mean at observation minus mean at baseline

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)	-1.1 mmHg Standard Deviation 7.1	-1.7 mmHg Standard Deviation 8.2

SECONDARY outcome

Timeframe: Week 6, baseline

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

Mean at observation minus mean at baseline

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 6 in Pulse Rate	0.9 bpm Standard Deviation 8.1	1.1 bpm Standard Deviation 9.0

SECONDARY outcome

Timeframe: Week 4, baseline

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

Change: mean of observation minus mean at baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in LDL at Week 4.	-0.5 mg/dL Standard Deviation 23.0	-47.8 mg/dL Standard Deviation 24.4

SECONDARY outcome

Timeframe: Week 4, baseline

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

Mean change at observation minus baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.	0.6 mg/dL Standard Deviation 5.8	0.6 mg/dL Standard Deviation 8.6

SECONDARY outcome

Timeframe: Week 4, baseline

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

Mean change at observation minus baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change in Total Cholesterol (TC) From Baseline to Week 4.	0.5 mg/dL Standard Deviation 23.5	-55.9 mg/dL Standard Deviation 26.8

SECONDARY outcome

Timeframe: Week 4, baseline

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

Mean change at observation minus baseline

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in Triglycerides (TG) to Week 4.	2.4 mg/dL Standard Deviation 73.2	-45.7 mg/dL Standard Deviation 62.8

SECONDARY outcome

Timeframe: Week 6, baseline

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

Mean change at observation minus baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in LDL at Week 6.	0.3 mg/dL Standard Deviation 24.8	-49.2 mg/dL Standard Deviation 24.0

SECONDARY outcome

Timeframe: Week 6, baseline

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

Mean change at observation minus baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in HDL at Week 6.	1.2 mg/dL Standard Deviation 8.2	0.4 mg/dL Standard Deviation 8.2

SECONDARY outcome

Timeframe: Week 6, baseline

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

Mean change at observation minus baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in Total Cholesterol (TC) to Week 6.	3.7 mg/dL Standard Deviation 23.8	-56.8 mg/dL Standard Deviation 28.4

SECONDARY outcome

Timeframe: Week 6 , baseline

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

Mean change at observation minus mean baseline.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline in Triglycerides (TG) at Week 6.	11.6 mg/dL Standard Deviation 115.3	-42.6 mg/dL Standard Deviation 67.3

SECONDARY outcome

Timeframe: Week 4, baseline

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

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.

Outcome measures

Measure	Norvasc + TLC n=115 Participants Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=118 Participants 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.
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.	-0.3 score on scale Standard Deviation 2.5	-2.8 score on scale Standard Deviation 3.3

Adverse Events

Norvasc + TLC

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Caduet + TLC

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Norvasc + TLC n=122 participants at risk Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.	Caduet + TLC n=122 participants at risk 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.
General disorders Oedema peripheral	6.6% 8/122	2.5% 3/122
Infections and infestations Urinary tract infection	2.5% 3/122	0.82% 1/122
Vascular disorders Hypertension	4.1% 5/122	2.5% 3/122

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER