Conditions: Dyslipidemia Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 245
Healthy volunteers: no

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:

Arms:
arm 1: Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks. arm 2: Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo. arm 3: Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks. arm 4: Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

Interventions: intervention 1: Amlodipine besylate intervention 2: Amlodipine besylate/atorvastatin calcium single pill combination intervention 3: Amlodipine besylate intervention 4: Amlodipine besylate/atorvastatin calcium single pill combination
Intervention descriptions: intervention 1: Amlodipine besylate 5 mg intervention 2: Amlodipine/atorvastatin single pill combination 10/20 mg intervention 3: Amlodipine besylate 10 mg intervention 4: Amlodipine/atorvastatin single pill combination 5/20 mg

Protocol document: