At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
In Brief
A Phase 4 clinical trial evaluating Amlodipine besylate and Amlodipine besylate/atorvastatin calcium single pill combination for Dyslipidemia and Hypertension. Completed, enrolled 245 participants across 51 sites.
Detailed 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.
Study Details
Timeline
Interventions
Amlodipine besylate 5 mg
Amlodipine/atorvastatin single pill combination 10/20 mg
Amlodipine besylate 10 mg
Amlodipine/atorvastatin single pill combination 5/20 mg