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Caduet in an Untreated Subject Population (CUSP)
This study has been completed.
First Received: June 1, 2006   Last Updated: August 19, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00332761
  Purpose

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.


Condition Intervention Phase
Hypertension
Dyslipidemia
 Drug: Caduet
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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. (CUSP - Caduet in Untreated Subject Population)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Caduet
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 220
Study Start Date: June 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332761

  Hide Study Locations
Locations
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72204
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Pfizer Investigational Site
Tustin, California, United States, 92780
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Garden Grove, California, United States, 92843
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Miami, Florida, United States, 33137
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33027
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
United States, Louisiana
Pfizer Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Michigan
Pfizer Investigational Site
Livonia, Michigan, United States, 48152
Pfizer Investigational Site
Fair Haven, Michigan, United States, 48023
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States, 39201
Pfizer Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
Pfizer Investigational Site
Excelsior Springs, Missouri, United States, 64024
United States, New Jersey
Pfizer Investigational Site
Berlin, New Jersey, United States, 08009
Pfizer Investigational Site
Elizabeth, New Jersey, United States, 07202
Pfizer Investigational Site
South Bound Brook, New Jersey, United States, 08880
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Pfizer Investigational Site
Binghamton, New York, United States, 13901
United States, North Carolina
Pfizer Investigational Site
Monroe, North Carolina, United States, 28112
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45406-5144
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45236
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Pfizer Investigational Site
Bensalem, Pennsylvania, United States, 19020
United States, Tennessee
Pfizer Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Pfizer Investigational Site
Beaumont, Texas, United States, 77702
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Temple, Texas, United States, 76502
Pfizer Investigational Site
Colleyville, Texas, United States, 76034
United States, Virginia
Pfizer Investigational Site
NORFOLK, Virginia, United States, 23510
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
Link to ClinicalStudyResults.org Posting:  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: A3841046
Study First Received: June 1, 2006
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00332761     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
 Dyslipidemias
Lipid Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009



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