Dyslipidemia, Hypertension
Conditions
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.
Interventions
Amlodipine besylate 5 mg
Amlodipine/atorvastatin single pill combination 10/20 mg
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Subjects With BP < 140/90 mmHg at Week 4 | Week 4 | Subjects achieving BP goal of \<140/90 mmHg at week 4 |
| Subjects With BP < 140/90 mmHg at Week 6 | Week 6 | Subjects achieving BP goal of \<140/90 mmHg at week 6 |
| Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). | Week 4, baseline | Mean at observation minus mean at baseline |
| Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) | Week 4, baseline | Mean at observation minus mean at baseline |
| 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). |
| Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) | Week 6, baseline | Mean change at observation minus mean baseline. |
| Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) | Week 6, baseline | Change from mean at observation minus mean at baseline |
| 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. |
| Change From Baseline in LDL at Week 4. | Week 4, baseline | Change: mean of observation minus mean at baseline. |
| Change From Baseline in High Density Lipoprotein (HDL) at Week 4. | Week 4, baseline | Mean change at observation minus baseline. |
| Change in Total Cholesterol (TC) From Baseline to Week 4. | Week 4, baseline | Mean change at observation minus baseline. |
| Change From Baseline in Triglycerides (TG) to Week 4. | Week 4, baseline | Mean change at observation minus baseline |
| Change From Baseline in LDL at Week 6. | Week 6, baseline | Mean change at observation minus baseline. |
| Change From Baseline in HDL at Week 6. | Week 6, baseline | Mean change at observation minus baseline. |
| Change From Baseline in Total Cholesterol (TC) to Week 6. | Week 6, baseline | Mean change at observation minus baseline. |
| Change From Baseline in Triglycerides (TG) at Week 6. | Week 6 , baseline | Mean change at observation minus mean baseline. |
| 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. |
| Change From Baseline to Week 6 in Pulse Rate | Week 6, baseline | Mean at observation minus mean at baseline |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 122 |
| 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. | 122 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 15 |
| Overall Study | did not receive treatment | 1 | 0 |
Baseline characteristics
| Characteristic | Norvasc + TLC | Caduet + TLC | Total |
|---|---|---|---|
| Age, Customized 18 to 64 years | 95 participants | 97 participants | 192 participants |
| Age, Customized > or = to 65 years | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 56 Participants | 65 Participants | 121 Participants |
| Sex: Female, Male Male | 66 Participants | 57 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 122 | 7 / 122 |
| serious Total, serious adverse events | 0 / 122 | 0 / 122 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk | -0.1 score on scale | Standard Deviation 2.9 |
| Caduet + TLC | Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk | -2.9 score on scale | Standard Deviation 3 |
Comparison: 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.p-value: <0.00195% CI: [-3.5, -2.1]ANCOVA
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)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | 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 |
| Caduet + TLC | 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 | 80 participants |
Comparison: 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.p-value: <0.00195% CI: [9.14, 39.63]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in HDL at Week 6.
Mean change at observation minus baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in HDL at Week 6. | 1.2 mg/dL | Standard Deviation 8.2 |
| Caduet + TLC | Change From Baseline in HDL at Week 6. | 0.4 mg/dL | Standard Deviation 8.2 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.p-value: 0.32995% CI: [-3.07, 1.03]ANCOVA
Secondary
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Mean change at observation minus baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in High Density Lipoprotein (HDL) at Week 4. | 0.6 mg/dL | Standard Deviation 5.8 |
| Caduet + TLC | Change From Baseline in High Density Lipoprotein (HDL) at Week 4. | 0.6 mg/dL | Standard Deviation 8.6 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.p-value: 0.73995% CI: [-2.07, 1.47]ANCOVA
Secondary
Change From Baseline in LDL at Week 4.
Change: mean of observation minus mean at baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in LDL at Week 4. | -0.5 mg/dL | Standard Deviation 23 |
| Caduet + TLC | Change From Baseline in LDL at Week 4. | -47.8 mg/dL | Standard Deviation 24.4 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.p-value: <0.00195% CI: [-54.68, -43.91]ANCOVA
Secondary
Change From Baseline in LDL at Week 6.
Mean change at observation minus baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in LDL at Week 6. | 0.3 mg/dL | Standard Deviation 24.8 |
| Caduet + TLC | Change From Baseline in LDL at Week 6. | -49.2 mg/dL | Standard Deviation 24 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.p-value: <0.00195% CI: [-56.88, -45.55]ANCOVA
Secondary
Change From Baseline in Total Cholesterol (TC) to Week 6.
Mean change at observation minus baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in Total Cholesterol (TC) to Week 6. | 3.7 mg/dL | Standard Deviation 23.8 |
| Caduet + TLC | Change From Baseline in Total Cholesterol (TC) to Week 6. | -56.8 mg/dL | Standard Deviation 28.4 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.p-value: <0.00195% CI: [-68.49, -55.65]ANCOVA
Secondary
Change From Baseline in Triglycerides (TG) at Week 6.
Mean change at observation minus mean baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in Triglycerides (TG) at Week 6. | 11.6 mg/dL | Standard Deviation 115.3 |
| Caduet + TLC | Change From Baseline in Triglycerides (TG) at Week 6. | -42.6 mg/dL | Standard Deviation 67.3 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.p-value: <0.00195% CI: [-77.61, -30.29]ANCOVA
Secondary
Change From Baseline in Triglycerides (TG) to Week 4.
Mean change at observation minus baseline
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline in Triglycerides (TG) to Week 4. | 2.4 mg/dL | Standard Deviation 73.2 |
| Caduet + TLC | Change From Baseline in Triglycerides (TG) to Week 4. | -45.7 mg/dL | Standard Deviation 62.8 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.p-value: <0.00195% CI: [-63.37, -31.16]ANCOVA
Secondary
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Mean at observation minus mean at baseline
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) | -1.5 mmHg | Standard Deviation 7.7 |
| Caduet + TLC | Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) | -1.2 mmHg | Standard Deviation 8.8 |
Comparison: 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.p-value: >0.99995% CI: [-2.01, 2.01]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk. | -0.3 score on scale | Standard Deviation 2.5 |
| Caduet + TLC | Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk. | -2.8 score on scale | Standard Deviation 3.3 |
Comparison: 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.p-value: <0.00195% CI: [-3.1, -1.7]ANCOVA
Secondary
Change From Baseline to Week 4 in Pulse Rate
Mean at observation minus mean at baseline measured in beats per minute (bpm).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 4 in Pulse Rate | -0.1 bpm | Standard Deviation 8.2 |
| Caduet + TLC | Change From Baseline to Week 4 in Pulse Rate | -0.9 bpm | Standard Deviation 8.5 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.p-value: 0.36395% CI: [-2.83, 1.04]ANCOVA
Secondary
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
Mean at observation minus mean at baseline
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). | -2.6 mmHg | Standard Deviation 12.1 |
| Caduet + TLC | Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). | -1.5 mmHg | Standard Deviation 11.9 |
Comparison: 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.p-value: 0.58595% CI: [-1.97, 3.48]ANCOVA
Secondary
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
Change from mean at observation minus mean at baseline
Time frame: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) | -1.1 mmHg | Standard Deviation 7.1 |
| Caduet + TLC | Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) | -1.7 mmHg | Standard Deviation 8.2 |
Comparison: 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.p-value: 0.35195% CI: [-2.71, 0.97]ANCOVA
Secondary
Change From Baseline to Week 6 in Pulse Rate
Mean at observation minus mean at baseline
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 6 in Pulse Rate | 0.9 bpm | Standard Deviation 8.1 |
| Caduet + TLC | Change From Baseline to Week 6 in Pulse Rate | 1.1 bpm | Standard Deviation 9 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.p-value: 0.92295% CI: [-1.91, 2.11]ANCOVA
Secondary
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
Mean change at observation minus mean baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) | -1.0 mmHg | Standard Deviation 12.6 |
| Caduet + TLC | Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) | -4.0 mmHg | Standard Deviation 11 |
Comparison: 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.p-value: 0.0295% CI: [-5.99, -0.51]ANCOVA
Secondary
Change in Total Cholesterol (TC) From Baseline to Week 4.
Mean change at observation minus baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norvasc + TLC | Change in Total Cholesterol (TC) From Baseline to Week 4. | 0.5 mg/dL | Standard Deviation 23.5 |
| Caduet + TLC | Change in Total Cholesterol (TC) From Baseline to Week 4. | -55.9 mg/dL | Standard Deviation 26.8 |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.p-value: <0.00195% CI: [-64.02, 51.81]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4 | 6 participants |
| Caduet + TLC | Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4 | 73 participants |
Comparison: 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.p-value: <0.00195% CI: [12.61, 78.09]Cochran-Mantel-Haenszel
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4. | 41 participants |
| Caduet + TLC | Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4. | 85 participants |
Comparison: 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.p-value: <0.00195% CI: [2.93, 9.24]Cochran-Mantel-Haenszel
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.
Time frame: Week 6
Population: Full analysis set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6. | 45 participants |
| Caduet + TLC | Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6. | 90 participants |
Comparison: 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.p-value: <0.00195% CI: [2.89, 9.11]Cochran-Mantel-Haenszel
Secondary
Subjects With BP < 140/90 mmHg at Week 4
Subjects achieving BP goal of \<140/90 mmHg at week 4
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With BP < 140/90 mmHg at Week 4 | 84 participants |
| Caduet + TLC | Subjects With BP < 140/90 mmHg at Week 4 | 87 participants |
Comparison: 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 4p-value: 0.78595% CI: [0.6, 1.98]Cochran-Mantel-Haenszel
Secondary
Subjects With BP < 140/90 mmHg at Week 6
Subjects achieving BP goal of \<140/90 mmHg at week 6
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With BP < 140/90 mmHg at Week 6 | 83 participants |
| Caduet + TLC | Subjects With BP < 140/90 mmHg at Week 6 | 94 participants |
Comparison: 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.p-value: 0.17195% CI: [0.83, 2.88]Cochran-Mantel-Haenszel
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With LDL-C < 100 mg/dL at Week 4 | 8 participants |
| Caduet + TLC | Subjects With LDL-C < 100 mg/dL at Week 4 | 96 participants |
Comparison: Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.p-value: <0.00195% CI: [27.1, 158.34]Cochran-Mantel-Haenszel
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norvasc + TLC | Subjects With LDL-C < 100 mg/dL at Week 6 | 13 participants |
| Caduet + TLC | Subjects With LDL-C < 100 mg/dL at Week 6 | 99 participants |
Comparison: 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.p-value: <0.00195% CI: [19.42, 90.99]Cochran-Mantel-Haenszel