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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia; Hypertension

Intervention: Amlodipine besylate (Drug); Amlodipine besylate/atorvastatin calcium single pill combination (Drug); Amlodipine besylate (Drug); Amlodipine besylate/atorvastatin calcium single pill combination (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

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

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

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

Subjects With BP < 140/90 mmHg at Week 4

Subjects With BP < 140/90 mmHg at Week 6

Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).

Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

Change From Baseline to Week 4 in Pulse Rate

Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)

Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

Change From Baseline to Week 6 in Pulse Rate

Change From Baseline in LDL at Week 4.

Change From Baseline in High Density Lipoprotein (HDL) at Week 4.

Change in Total Cholesterol (TC) From Baseline to Week 4.

Change From Baseline in Triglycerides (TG) to Week 4.

Change From Baseline in LDL at Week 6.

Change From Baseline in HDL at Week 6.

Change From Baseline in Total Cholesterol (TC) to Week 6.

Change From Baseline in Triglycerides (TG) at Week 6.

Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Pfizer Investigational Site, Birmingham, Alabama 35209, United States

Pfizer Investigational Site, Birmingham, Alabama 35216, United States

Pfizer Investigational Site, Birmingham, Alabama 35234, United States

Pfizer Investigational Site, Mesa, Arizona 85206, United States

Pfizer Investigational Site, Garden Grove, California 92843, United States

Pfizer Investigational Site, Mission Viejo, California 92692, United States

Pfizer Investigational Site, Rancho Santa Margarita, California 92688, United States

Pfizer Investigational Site, Torrance, California 90502, United States

Pfizer Investigational Site, Gainesville, Florida 32605, United States

Pfizer Investigational Site, Kissimmee, Florida 34741, United States

Pfizer Investigational Site, Melbourne, Florida 32935, United States

Pfizer Investigational Site, Miami, Florida 33176, United States

Pfizer Investigational Site, Safety Harbor, Florida 34695, United States

Pfizer Investigational Site, St. Petersburg, Florida 33701, United States

Pfizer Investigational Site, Augusta, Georgia 30904, United States

Pfizer Investigational Site, Tucker, Georgia 30084, United States

Pfizer Investigational Site, South Bend, Indiana 46601, United States

Pfizer Investigational Site, Erlanger, Kentucky 41018, United States

Pfizer Investigational Site, Auburn, Maine 04210, United States

Pfizer Investigational Site, Warren, Michigan 48091, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55404, United States

Pfizer Investigational Site, Chesterfield, Missouri 63017, United States

Pfizer Investigational Site, Florissant, Missouri 63031, United States

Pfizer Investigational Site, Omaha, Nebraska 68116-2004, United States

Pfizer Investigational Site, Henderson, Nevada 89014, United States

Pfizer Investigational Site, Henderson, Nevada 89015, United States

Pfizer Investigational Site, Belvidere, New Jersey 07823, United States

Pfizer Investigational Site, Bridgewater, New Jersey 08807, United States

Pfizer Investigational Site, Clifton, New Jersey 07013, United States

Pfizer Investigational Site, Elizabeth, New Jersey 07202, United States

Pfizer Investigational Site, Hillsborough, New Jersey 08844, United States

Pfizer Investigational Site, Trenton, New Jersey 08618, United States

Pfizer Investigational Site, Brooklyn, New York 11229, United States

Pfizer Investigational Site, Buffalo, New York 14209, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73103, United States

Pfizer Investigational Site, Tulsa, Oklahoma 74136, United States

Pfizer Investigational Site, Bensalem, Pennsylvania 19020, United States

Pfizer Investigational Site, Lansdale, Pennsylvania 19446, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19146, United States

Pfizer Investigational Site, Providence, Rhode Island 02904, United States

Pfizer Investigational Site, Goose Creek, South Carolina 29445, United States

Pfizer Investigational Site, Mount Pleasant, South Carolina 29464, United States

Pfizer Investigational Site, Bristol, Tennessee 37620, United States

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States

Pfizer Investigational Site, Dallas, Texas 75235, United States

Pfizer Investigational Site, Houston, Texas 77030-2324, United States

Pfizer Investigational Site, Plano, Texas 75093, United States

Pfizer Investigational Site, San Antonio, Texas 78238, United States

Pfizer Investigational Site, Chesapeake, Virginia 23320, United States

Additional Information

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

Starting date: January 2007
Last updated: November 12, 2009

Page last updated: August 20, 2015

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