Shiga Microalbuminuria Reduction Trial-2

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461499
• Other study ID #: SMART-2
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: August 15, 2017
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science	Otsu	Shiga

Sponsors (1)

Lead Sponsor	Collaborator
Shiga University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Albuminuria	Change in the urinary albumin to creatinine ratio (UACR) from the baseline	baseline and 24 weeks
Secondary	Change in the Urinary Angiotensinogen Level	Change in the urinaryurinary angiotensinogen level from the baseline	baseline and 24 weeks
Secondary	Change in the Plasma Renin Activity		baseline and 24 weeks
Secondary	Change in the Serum Insulin Level		baseline and 24 weeks