Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1,825 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,825

Conditions

Hypertension Hyperlipidemia

Interventions

Amlodipine/atorvastatin single pillDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (118)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

St Leonards, New South Wales, Australia

Pfizer Investigational Site

Southport, Queensland, Australia

Pfizer Investigational Site

Woolloongabba, Queensland, Australia

Pfizer Investigational Site

Heidelberg, Victoria, Australia

Pfizer Investigational Site

Melbourne, Victoria, Australia

...and 108 more locations