Shiga Microalbuminuria Reduction Trial-2

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypertension
• Interventions: Drug: any angiotensin receptor blockers; Drug: Aliskiren

• Registration Number: NCT01461499
• Lead Sponsor: Shiga University

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 pressure control with angiotensin receptor blocker (ARB).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Results First Submitted: 2016-11-11
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-15
• Last Update Submitted: 2017-08-15
• Results First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiotensin receptor blockers	any angiotensin receptor blockers	-
Direct renin inhibitor	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
Reduction in Albuminuria	baseline and 24 weeks	Change in the urinary albumin to creatinine ratio (UACR) from the baseline

Secondary Outcome Measures

Name	Time	Method
Change in the Urinary Angiotensinogen Level	baseline and 24 weeks	Change in the urinaryurinary angiotensinogen level from the baseline
Change in the Plasma Renin Activity	baseline and 24 weeks
Change in the Serum Insulin Level	baseline and 24 weeks

Trial Locations

Locations (1)

Shiga University of Medical Science; 🇯🇵 Otsu, Shiga, Japan