NCT01461499

Shiga Microalbuminuria Reduction Trial-2

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Shiga University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus
• Hypertension

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2011-10-28
• Last updated: 2018-02-19
• Results posted: 2018-02-19

Locations

1 site across 1 country: Japan