CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 237 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 150 mgfrom 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/NCT01461499
NCT01461499Phase 4Completed
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Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2

Shiga University·interventional·Posted Oct 28, 2011·Updated Feb 19, 2018

In Brief

A Phase 4 clinical trial evaluating Aliskiren and any angiotensin receptor blockers for Type 2 Diabetes Mellitus and Hypertension. Completed, enrolled 237 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Hypertension
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.7 years ago

Interventions

Aliskirendrug

The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

any angiotensin receptor blockersdrug

The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.