Clinical trial NCT00332761: Caduet in an Untreated Subject Population
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
Secondary outcomes:
measure: The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
measure: Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
measure: Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
measure: The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
measure: Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
measure: Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
measure: The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Bossier City
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Fair Haven
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Livonia
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Excelsior Springs
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Berlin
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Elizabeth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: South Bound Brook
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Binghamton
country: United States
facility: Pfizer Investigational Site
state: New York
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bensalem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Colleyville
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: