Shiga Microalbuminuria Reduction Trial-2

Shiga University

Status and phase

Completed

Phase 4

Conditions

Hypertension

Type 2 Diabetes Mellitus

Treatments

Drug: any angiotensin receptor blockers

Drug: Aliskiren

Study type

Interventional

Funder types

Other

Identifiers

NCT01461499

SMART-2

Details and patient eligibility

About

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).

Enrollment

237 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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