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

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

Official Title

Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia

Conditions

Hypertension, Hyperlipidemia

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

• Primary Outcome Measures: 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 Outcome Measures: 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

Study Start

May 2004; Study completion: July 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 80 Years
• Genders Eligible for Study: Both

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

Total Enrolment

1825

Contact Details

Australian Locations

• Pfizer Investigational Site, St. Leonards, New South Wales, 2065, Australia
• Pfizer Investigational Site, Southport, Queensland, 4215, Australia
• Pfizer Investigational Site, Woolloongabba, Queensland, 4102, Australia
• Pfizer Investigational Site, Prahran, Victoria, 3181, Australia
• Pfizer Investigational Site, Melbourne, Victoria, 3004, Australia
• Pfizer Investigational Site, Heidelberg, Victoria, 3084, Australia
• Pfizer Investigational Site, Fremantle, Western Australia, 6160, Australia

Results and Contacts