Status:
COMPLETED
Shiga Microalbuminuria Reduction Trial-2
Lead Sponsor:
Shiga University
Conditions:
Type 2 Diabetes Mellitus
Hypertension
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief 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 pres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01461499
Start Date
October 1 2011
End Date
December 1 2014
Last Update
February 19 2018
Active Locations (1)
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1
Shiga University of Medical Science
Ōtsu, Shiga, Japan, 520-2192