Shiga Microalbuminuria Reduction Trial-2

August 15, 2017 updated by: Hiroshi Maegawa, Shiga University

Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct renin inhibitor
Drug: Aliskiren
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.
Active Comparator: Angiotensin receptor blockers
Drug: any angiotensin receptor blockers
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Albuminuria
Time Frame: baseline and 24 weeks
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Urinary Angiotensinogen Level
Time Frame: baseline and 24 weeks
Change in the urinaryurinary angiotensinogen level from the baseline
baseline and 24 weeks
Change in the Plasma Renin Activity
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change in the Serum Insulin Level
Time Frame: baseline and 24 weeks
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiga University

Investigators

  • Study Chair: Hiroshi Maegawa, M.D., Shiga University of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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