Caduet in an Untreated Subject Population

Hypertension Clinical Trial

— CUSP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332761
• Other study ID #: A3841046
• Status: Completed
• Phase: Phase 4
• Start date: June 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Caduet

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bensalem	Pennsylvania
United States	Pfizer Investigational Site	Berlin	New Jersey
United States	Pfizer Investigational Site	Binghamton	New York
United States	Pfizer Investigational Site	Bossier City	Louisiana
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Colleyville	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Elizabeth	New Jersey
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Excelsior Springs	Missouri
United States	Pfizer Investigational Site	Fair Haven	Michigan
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Livonia	Michigan
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Monroe	North Carolina
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Princeton	New Jersey
United States	Pfizer Investigational Site	South Bound Brook	New Jersey
United States	Pfizer Investigational Site	Temple	Texas
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
Secondary	The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
Secondary	Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
Secondary	Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
Secondary	The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
Secondary	Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
Secondary	Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
Secondary	The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.

External Links

•   To obtain contact information for a study center near you, click here.