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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
245
Amlodipine besylate 5 mg
Amlodipine/atorvastatin single pill combination 10/20 mg
Amlodipine besylate 10 mg
Amlodipine/atorvastatin single pill combination 5/20 mg
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Garden Grove, California, United States
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
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
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
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
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
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
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
Subjects With BP < 140/90 mmHg at Week 4
Subjects achieving BP goal of \<140/90 mmHg at week 4
Time frame: Week 4
Subjects With BP < 140/90 mmHg at Week 6
Subjects achieving BP goal of \<140/90 mmHg at week 6
Time frame: Week 6
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
Mean at observation minus mean at baseline
Time frame: Week 4, baseline
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Mean at observation minus mean at baseline
Time frame: Week 4, baseline
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
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
Mean change at observation minus mean baseline.
Time frame: Week 6, baseline
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
Change From Baseline to Week 6 in Pulse Rate
Mean at observation minus mean at baseline
Time frame: Week 6, baseline
Change From Baseline in LDL at Week 4.
Change: mean of observation minus mean at baseline.
Time frame: Week 4, baseline
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Mean change at observation minus baseline.
Time frame: Week 4, baseline
Change in Total Cholesterol (TC) From Baseline to Week 4.
Mean change at observation minus baseline.
Time frame: Week 4, baseline
Change From Baseline in Triglycerides (TG) to Week 4.
Mean change at observation minus baseline
Time frame: Week 4, baseline
Change From Baseline in LDL at Week 6.
Mean change at observation minus baseline.
Time frame: Week 6, baseline
Change From Baseline in HDL at Week 6.
Mean change at observation minus baseline.
Time frame: Week 6, baseline
Change From Baseline in Total Cholesterol (TC) to Week 6.
Mean change at observation minus baseline.
Time frame: Week 6, baseline
Change From Baseline in Triglycerides (TG) at Week 6.
Mean change at observation minus mean baseline.
Time frame: Week 6 , baseline
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
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Pfizer Investigational Site
Mission Viejo, California, United States
Pfizer Investigational Site
Rancho Santa Margarita, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Kissimmee, Florida, United States
...and 41 more locations