Overview

Caduet in an Untreated Subject Population

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Amlodipine, atorvastatin drug combination
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.