CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
amlodipine, hydralazine, terazosin or hydrochlorothiazidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02046395
NCT02046395Phase 4Completed
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Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus

Tulane University School of Medicine·interventional·Posted Jan 27, 2014·Updated Aug 21, 2023

In Brief

A Phase 4 clinical trial evaluating amlodipine, hydralazine, terazosin or hydrochlorothiazide for Type 2 Diabetes and Hypertension. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 12.4 years ago

Interventions

amlodipine, hydralazine, terazosin or hydrochlorothiazidedrug

In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.