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Caduet in an Untreated Subject Population.

Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Dyslipidemia

Intervention: Caduet (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 determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.

Clinical Details

Official title: An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining the Efficacy and Safety of Caduet in Simultaneously Achieving Blood Pressure and Lipid Goals in an Untreated Hypertensive and Dyslipidemic Subject Population.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.

Secondary outcome:

The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.

Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.

Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.

The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.

Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.

Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.

The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.

Eligibility

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

Criteria:

Inclusion Criteria:

- Subjects who were recently diagnosed with both hypertension and dyslipidemia and who

are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.

- SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL

Exclusion Criteria:

- Subjects with a history of MI, angina, coronary artery bypass or intra-coronary

interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.

- Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood

glucose > 126 mg/dL at the Screening visit.

Locations and Contacts

Pfizer Investigational Site, Little Rock, Arkansas 72204, United States

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States

Pfizer Investigational Site, Tustin, California 92780, United States

Pfizer Investigational Site, Long Beach, California 90806, United States

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

Pfizer Investigational Site, Aventura, Florida 33180, United States

Pfizer Investigational Site, Miami, Florida 33137, United States

Pfizer Investigational Site, Ft. Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33027, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Atlanta, Georgia 30309, United States

Pfizer Investigational Site, Bossier City, Louisiana 71111, United States

Pfizer Investigational Site, Livonia, Michigan 48152, United States

Pfizer Investigational Site, Fair Haven, Michigan 48023, United States

Pfizer Investigational Site, Jackson, Mississippi 39201, United States

Pfizer Investigational Site, Jackson, Mississippi 39202, United States

Pfizer Investigational Site, Excelsior Springs, Missouri 64024, United States

Pfizer Investigational Site, Berlin, New Jersey 08009, United States

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

Pfizer Investigational Site, South Bound Brook, New Jersey 08880, United States

Pfizer Investigational Site, Princeton, New Jersey 08540, United States

Pfizer Investigational Site, Binghamton, New York 13901, United States

Pfizer Investigational Site, Monroe, North Carolina 28112, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Dayton, Ohio 45406-5144, United States

Pfizer Investigational Site, Cincinnati, Ohio 45236, United States

Pfizer Investigational Site, Eugene, Oregon 97404, United States

Pfizer Investigational Site, Bensalem, Pennsylvania 19020, United States

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States

Pfizer Investigational Site, Beaumont, Texas 77702, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Temple, Texas 76502, United States

Pfizer Investigational Site, Colleyville, Texas 76034, United States

Pfizer Investigational Site, NORFOLK, Virginia 23510, United States

Additional Information

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

Starting date: June 2006
Ending date: September 2007
Last updated: September 28, 2007

Page last updated: June 20, 2008

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