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Caduet in an Untreated Subject Population (CUSP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332761
First Posted: June 2, 2006
Last Update Posted: August 20, 2008
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.
Information provided by:
Pfizer
  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 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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

Information from the National Library of Medicine

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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
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00332761     History of Changes
Other Study ID Numbers: A3841046
First Submitted: June 1, 2006
First Posted: June 2, 2006
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