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

Completed · Phase 4

Conditions studied: Dyslipidemia, Hypertension

In brief

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.

Key facts

Study ID

NCT00412113

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

245

Starts

2007-01-01

Expected to finish

2008-04-01

Last updated by the study team

2021-02-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

You may not qualify if…

• Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
• Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
• Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Garden Grove, California, United States
• Pfizer Investigational Site — Mission Viejo, California, United States
• Pfizer Investigational Site — Rancho Santa Margarita, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Kissimmee, Florida, United States
• Pfizer Investigational Site — Melbourne, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Safety Harbor, Florida, United States
• Pfizer Investigational Site — St. Petersburg, Florida, United States
• Pfizer Investigational Site — Augusta, Georgia, United States
• Pfizer Investigational Site — Tucker, Georgia, United States
• Pfizer Investigational Site — South Bend, Indiana, United States
• Pfizer Investigational Site — Erlanger, Kentucky, United States
• Pfizer Investigational Site — Auburn, Maine, United States
• Pfizer Investigational Site — Warren, Michigan, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Chesterfield, Missouri, United States
• Pfizer Investigational Site — Florissant, Missouri, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Henderson, Nevada, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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