Caduet in an Untreated Subject Population
Phase 4
Completed
- Conditions
- HypertensionDyslipidemia
- Registration Number
- NCT00332761
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of amlodipine and atorvastatin combination therapy in Caduet® (NCT00332761) contribute to simultaneous blood pressure and lipid control in untreated hypertensive and dyslipidemic patients?
How does the efficacy of Caduet® (amlodipine/atorvastatin) in achieving BP <140/90 mmHg and LDL <100 mg/dL compare to standard monotherapies for hypertension and dyslipidemia in NCT00332761?
What biomarkers correlate with response to combined calcium channel blocker and statin therapy in the NCT00332761 trial of untreated hypertensive/dyslipidemic subjects?
What adverse event profiles were observed in NCT00332761 for amlodipine/atorvastatin combination therapy versus placebo in dual untreated hypertension and dyslipidemia populations?
How does the amlodipine/atorvastatin combination in Caduet® compare to other fixed-dose antihypertensive/statin therapies in managing untreated combined hypertension and dyslipidemia (NCT00332761)?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Norfolk, Virginia, United States
Pfizer Investigational Site🇺🇸Norfolk, Virginia, United States