Caduet in an Untreated Subject Population
CUSP
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)
1 other identifier
interventional
220
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jun 2006
Shorter than P25 for phase_4 hypertension
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 27, 2021
January 1, 2021
June 1, 2006
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
Secondary Outcomes (7)
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.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Pfizer Investigational Site
Jonesboro, Arkansas, 72401, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72204, United States
Pfizer Investigational Site
Garden Grove, California, 92843, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Tustin, California, 92780, United States
Pfizer Investigational Site
Aventura, Florida, 33180, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308, United States
Pfizer Investigational Site
Miami, Florida, 33137, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33027, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Bossier City, Louisiana, 71111, United States
Pfizer Investigational Site
Fair Haven, Michigan, 48023, United States
Pfizer Investigational Site
Livonia, Michigan, 48152, United States
Pfizer Investigational Site
Jackson, Mississippi, 39201, United States
Pfizer Investigational Site
Jackson, Mississippi, 39202, United States
Pfizer Investigational Site
Excelsior Springs, Missouri, 64024, United States
Pfizer Investigational Site
Berlin, New Jersey, 08009, United States
Pfizer Investigational Site
Elizabeth, New Jersey, 07202, United States
Pfizer Investigational Site
Princeton, New Jersey, 08540, United States
Pfizer Investigational Site
South Bound Brook, New Jersey, 08880, United States
Pfizer Investigational Site
Binghamton, New York, 13901, United States
Pfizer Investigational Site
Monroe, North Carolina, 28112, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45236, United States
Pfizer Investigational Site
Dayton, Ohio, 45406-5144, United States
Pfizer Investigational Site
Eugene, Oregon, 97404, United States
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020, United States
Pfizer Investigational Site
Kingsport, Tennessee, 37660, United States
Pfizer Investigational Site
Beaumont, Texas, 77702, United States
Pfizer Investigational Site
Colleyville, Texas, 76034, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Temple, Texas, 76502, United States
Pfizer Investigational Site
Norfolk, Virginia, 23510, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
June 1, 2006
Study Completion
September 1, 2007
Last Updated
January 27, 2021
Record last verified: 2021-01