Amlodipine Diabetic Hypertension Efficacy Response Trial

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00159692
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of \<130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study Completion: 2005-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

• Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges).

Exclusion Criteria

• A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation).

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects at SBP goal of <130 mmHg and DBP goal of <80mmHg; change from baseline blood pressures (SBP and DBP); percentage of subjects with SBP >160mmHg and/or DBP >100mmHg at Visits 2, 3, 4, 5, 6.