ADHERE: Amlodipine Diabetic Hypertension Efficacy Response Trial
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00159692
Collaborator
(none)
739
29
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
739 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects
Study Start Date
:
Mar 1, 2003
Actual Study Completion Date
:
Aug 1, 2005
Outcome Measures
Primary Outcome Measures
- 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
- 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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00159692
Other Study ID Numbers:
- A0531063
First Posted:
Sep 12, 2005
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021