Shiga Microalbuminuria Reduction Trial-2

Shiga University237 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

237

Conditions

Type 2 Diabetes Mellitus Hypertension

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Segment: outpatients * Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg * Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment * Microalbuminuria: 10 \< and \< 300 mg/gCr * Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent Exclusion Criteria: * Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension * Type 1 diabetes * Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren * Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption * Serum potassium \> 5.6 mEq/L (hyperkalemia) * Urinary microalbumin \< 10 or \> 300 mg/gCr * Patients who participated in another clinical study within three months

Locations (1)

Shiga University of Medical Science

Ōtsu, Shiga, Japan

Outcomes

Primary Outcomes

Reduction in Albuminuria

Change in the urinary albumin to creatinine ratio (UACR) from the baseline

Time frame: baseline and 24 weeks

Secondary Outcomes

Change in the Urinary Angiotensinogen Level

Change in the urinaryurinary angiotensinogen level from the baseline

Time frame: baseline and 24 weeks

Change in the Plasma Renin Activity

Time frame: baseline and 24 weeks

Change in the Serum Insulin Level

Time frame: baseline and 24 weeks

Data from ClinicalTrials.gov

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