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

Condition(s) targeted: Hypertension; Hyperlipidemia

Intervention: Amlodipine/atorvastatin single pill (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Primary outcome: 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: 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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

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Link to ClinicalStudyResults.org Posting

Starting date: May 2004
Ending date: July 2005
Last updated: July 24, 2006