Amlodipine Diabetic Hypertension Efficacy Response Trial

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159692

Acronym

ADHERE

Enrollment

739

Registered

2005-09-12

Start date

2003-03-31

Completion date

2005-08-31

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGAmlodipine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026