Shiga Microalbuminuria Reduction Trial-2

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiga University
• Treatments: Angiotensin Receptor Antagonists

Criteria

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