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

NCT00412113 | Completed Phase 4 Results

• 1 other identifier: A3841045
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 51

Brief 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

Outcome Measures

Primary Outcomes (2)

• Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

  Number of subjects reaching dual goal of systolic blood pressure \<140 millimeters of mercury (mmHg) and diastolic blood pressue of \<90 mmHg and low density lipoprotein-cholesterol(LDL-C) \<100 milligrams per deciliter(mg/dL)

  Week 6

• Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

  Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction \[MI\] or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

  Week 6, baseline

Secondary Outcomes (22)

• Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

  Week 4

• Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

  Week 4

• Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

  Week 6

• Subjects With LDL-C < 100 mg/dL at Week 4

  Week 4

• Subjects With LDL-C < 100 mg/dL at Week 6

  Week 6

Study Arms (4)

Norvasc 5 mg

ACTIVE COMPARATOR

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

Drug: Amlodipine besylate

Caduet 10/20mg

EXPERIMENTAL

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

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Norvasc 10 mg

ACTIVE COMPARATOR

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

Drug: Amlodipine besylate

Caduet 5/20mg

EXPERIMENTAL

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

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Interventions

Amlodipine besylate DRUG

Amlodipine besylate 5 mg

Norvasc 5 mg

Amlodipine besylate/atorvastatin calcium single pill combination DRUG

Amlodipine/atorvastatin single pill combination 10/20 mg

Caduet 10/20mg

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

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

Study Sites (51)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35216, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35234, United States

Location

Pfizer Investigational Site

Mesa, Arizona, 85206, United States

Location

Pfizer Investigational Site

Garden Grove, California, 92843, United States

Location

Pfizer Investigational Site

Mission Viejo, California, 92692, United States

Location

Pfizer Investigational Site

Rancho Santa Margarita, California, 92688, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

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Pfizer Investigational Site

Gainesville, Florida, 32605, United States

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Pfizer Investigational Site

Kissimmee, Florida, 34741, United States

Location

Pfizer Investigational Site

Melbourne, Florida, 32935, United States

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Pfizer Investigational Site

Miami, Florida, 33176, United States

Location

Pfizer Investigational Site

Safety Harbor, Florida, 34695, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33701, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30904, United States

Location

Pfizer Investigational Site

Tucker, Georgia, 30084, United States

Location

Pfizer Investigational Site

South Bend, Indiana, 46601, United States

Location

Pfizer Investigational Site

Erlanger, Kentucky, 41018, United States

Location

Pfizer Investigational Site

Auburn, Maine, 04210, United States

Location

Pfizer Investigational Site

Warren, Michigan, 48091, United States

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Pfizer Investigational Site

Minneapolis, Minnesota, 55404, United States

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Pfizer Investigational Site

Chesterfield, Missouri, 63017, United States

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Pfizer Investigational Site

Florissant, Missouri, 63031, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68116-2004, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89014, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89015, United States

Location

Pfizer Investigational Site

Belvidere, New Jersey, 07823, United States

Location

Pfizer Investigational Site

Bridgewater, New Jersey, 08807, United States

Location

Pfizer Investigational Site

Clifton, New Jersey, 07013, United States

Location

Pfizer Investigational Site

Elizabeth, New Jersey, 07202, United States

Location

Pfizer Investigational Site

Hillsborough, New Jersey, 08844, United States

Location

Pfizer Investigational Site

Trenton, New Jersey, 08618, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11229, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14209, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45242, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

Pfizer Investigational Site

Bensalem, Pennsylvania, 19020, United States

Location

Pfizer Investigational Site

Lansdale, Pennsylvania, 19446, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19146, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, 02904, United States

Location

Pfizer Investigational Site

Goose Creek, South Carolina, 29445, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

Location

Pfizer Investigational Site

Kingsport, Tennessee, 37660, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030-2324, United States

Location

Pfizer Investigational Site

Plano, Texas, 75093, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78238, United States

Location

Pfizer Investigational Site

Chesapeake, Virginia, 23320, United States

Location

Related Links

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

MeSH Terms

Conditions

Dyslipidemias; Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 15, 2006
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 11, 2021
• Results First Posted: November 6, 2009

Record last verified: 2021-01

Locations

US (51)