Dyslipidemia, Hypertension
Conditions
Brief summary
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population
Interventions
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated * Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening
Exclusion criteria
* Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet * Subjects with blood pressure at goal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP | — |
Countries
United States
Outcome results
None listed