Caduet in an Untreated Subject Population

Phase 4

Completed

• Conditions: Hypertension; Dyslipidemia

• 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

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Study Completion: 2007-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Norfolk, Virginia, United States