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Caduet in an Untreated Subject Population (CUSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00332761
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : August 20, 2008
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Caduet Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : June 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Caduet




Primary Outcome Measures :
  1. 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 :
  1. The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
  2. Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
  3. Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
  4. The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
  5. Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
  6. Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
  7. The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332761


Locations
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United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
Pfizer Investigational Site
Garden Grove, California, United States, 92843
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Tustin, California, United States, 92780
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Miami, Florida, United States, 33137
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33027
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
United States, Louisiana
Pfizer Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Michigan
Pfizer Investigational Site
Fair Haven, Michigan, United States, 48023
Pfizer Investigational Site
Livonia, Michigan, United States, 48152
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
Princeton, New Jersey, United States, 08540
Pfizer Investigational Site
South Bound Brook, New Jersey, United States, 08880
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
Cincinnati, Ohio, United States, 45236
Pfizer Investigational Site
Dayton, Ohio, United States, 45406-5144
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
Colleyville, Texas, United States, 76034
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Temple, Texas, United States, 76502
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00332761    
Other Study ID Numbers: A3841046
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors