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

NCT ID: NCT00412113

Last Updated: 2021-02-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Norvasc 5 mg

Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.

Group Type ACTIVE_COMPARATOR

Amlodipine besylate

Intervention Type DRUG

Amlodipine besylate 5 mg

Caduet 10/20mg

Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.

Group Type EXPERIMENTAL

Amlodipine besylate/atorvastatin calcium single pill combination

Intervention Type DRUG

Amlodipine/atorvastatin single pill combination 10/20 mg

Norvasc 10 mg

Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.

Group Type ACTIVE_COMPARATOR

Amlodipine besylate

Intervention Type DRUG

Amlodipine besylate 10 mg

Caduet 5/20mg

Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

Group Type EXPERIMENTAL

Amlodipine besylate/atorvastatin calcium single pill combination

Intervention Type DRUG

Amlodipine/atorvastatin single pill combination 5/20 mg

Interventions

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Amlodipine besylate

Amlodipine besylate 5 mg

Intervention Type DRUG

Amlodipine besylate/atorvastatin calcium single pill combination

Amlodipine/atorvastatin single pill combination 10/20 mg

Intervention Type DRUG

Amlodipine besylate

Amlodipine besylate 10 mg

Intervention Type DRUG

Amlodipine besylate/atorvastatin calcium single pill combination

Amlodipine/atorvastatin single pill combination 5/20 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Pfizer Investigational Site

Mesa, Arizona, United States

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Garden Grove, California, United States

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Mission Viejo, California, United States

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Rancho Santa Margarita, California, United States

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Torrance, California, United States

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Gainesville, Florida, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Safety Harbor, Florida, United States

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St. Petersburg, Florida, United States

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Augusta, Georgia, United States

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Tucker, Georgia, United States

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South Bend, Indiana, United States

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Erlanger, Kentucky, United States

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Auburn, Maine, United States

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Warren, Michigan, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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Florissant, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Henderson, Nevada, United States

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Belvidere, New Jersey, United States

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Bridgewater, New Jersey, United States

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Clifton, New Jersey, United States

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Elizabeth, New Jersey, United States

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Hillsborough, New Jersey, United States

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Trenton, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bensalem, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Goose Creek, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Pfizer Investigational Site

Chesapeake, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841045&StudyName=A%20Multi-Risk%20Factor%20Strategy%20Vs%20A%20Guideline-Based%20Approach%20In%20Achieving%20Blood%20Pressure%20%26%20Lipid%20Goals%20In%20Hypertensives%20At%20Extra%20Risk

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3841045

Identifier Type: -

Identifier Source: org_study_id

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