Hyperlipidemia, Hypertension
Conditions
Brief summary
The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines
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
No
Inclusion criteria
* Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication
Exclusion criteria
* Patients with blood pressure adequately maintained at goal with or without medication * Patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of amlodipine/atorvastatin 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 changes from baseline in lipid profile and systolic and diastolic BP after 14 weeks treatment; and in this secondary and the primary objectives stratified by prior BP and lipid therapy, and in diabetic subjects; safety | — |
Countries
Argentina, Australia, Brazil, Chile, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Peru, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed