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Caduet in an Untreated Subject Population (CUSP)

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ClinicalTrials.gov Identifier: NCT00332761
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : August 20, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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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.

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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.
Contacts and Locations
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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


  Show 34 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00332761     History of Changes
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:
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors