NCT00412113

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia
• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine besylate	Amlodipine besylate 5 mg
DRUG	Amlodipine besylate/atorvastatin calcium single pill combination	Amlodipine/atorvastatin single pill combination 10/20 mg
DRUG	Amlodipine besylate	Amlodipine besylate 10 mg
DRUG	Amlodipine besylate/atorvastatin calcium single pill combination	Amlodipine/atorvastatin single pill combination 5/20 mg

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-12-15
• Last updated: 2021-02-11
• Results posted: 2009-11-06

Locations

51 sites across 1 country: United States