Caduet in an Untreated Subject Population

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332761

Acronym

CUSP

Enrollment

220

Registered

2006-06-02

Start date

2006-06-30

Completion date

2007-09-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension

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.

Interventions

DRUGCaduet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.	—

Secondary

Measure	Time frame
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.	—
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.	—
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.	—
Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026