drugset / Trial / NCT00412113

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

NCT00412113

Phase 4 Completed 245 enrolled Viatris Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Timeline

Start
2007-01
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg
Subject Amlodipine Other / unclassified 10 mg
Subject Atorvastatin Small molecule 20 mg