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

Phase 4

Completed

Conditions: Dyslipidemia
Hypertension

Interventions: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Drug: Amlodipine besylate

Registration Number: NCT00412113

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 245

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caduet 10/20mg	Amlodipine besylate/atorvastatin calcium single pill combination	Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
Caduet 5/20mg	Amlodipine besylate/atorvastatin calcium single pill combination	Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .
Norvasc 5 mg	Amlodipine besylate	Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
Norvasc 10 mg	Amlodipine besylate	Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 BP < 140/90 mmHg at Week 4	Week 4	Subjects achieving BP goal of \<140/90 mmHg at week 4
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 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
Change From Baseline in LDL at Week 4.	Week 4, baseline	Change: mean of 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.
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 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 6	Week 6	Subjects achieving BP goal of \<140/90 mmHg at week 6
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 Systolic Blood Pressure (SBP).	Week 4, baseline	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
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.