Caduet in an Untreated Subject Population (CUSP)

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72204
        • Pfizer Investigational Site
    • California
      • Garden Grove, California, United States, 92843
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Tustin, California, United States, 92780
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33137
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Pfizer Investigational Site
    • Michigan
      • Fair Haven, Michigan, United States, 48023
        • Pfizer Investigational Site
      • Livonia, Michigan, United States, 48152
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
      • Jackson, Mississippi, United States, 39201
        • Pfizer Investigational Site
    • Missouri
      • Excelsior Springs, Missouri, United States, 64024
        • Pfizer Investigational Site
    • New Jersey
      • 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
        • Pfizer Investigational Site
    • New York
      • Binghamton, New York, United States, 13901
        • Pfizer Investigational Site
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45406-5144
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Pfizer Investigational Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • 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
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (ESTIMATE)

June 2, 2006

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3841046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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