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Shiga Microalbuminuria Reduction Trial-2

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ClinicalTrials.gov Identifier: NCT01461499
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hiroshi Maegawa, Shiga University

October 19, 2011
October 28, 2011
November 11, 2016
February 19, 2018
February 19, 2018
October 2011
August 2014   (Final data collection date for primary outcome measure)
Reduction in Albuminuria [ Time Frame: baseline and 24 weeks ]
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
Same as current
Complete list of historical versions of study NCT01461499 on ClinicalTrials.gov Archive Site
  • Change in the Urinary Angiotensinogen Level [ Time Frame: baseline and 24 weeks ]
    Change in the urinaryurinary angiotensinogen level from the baseline
  • Change in the Plasma Renin Activity [ Time Frame: baseline and 24 weeks ]
  • Change in the Serum Insulin Level [ Time Frame: baseline and 24 weeks ]
  • Change in the Urinary Angiotensinogen Level [ Time Frame: baseline and 24 weeks ]
  • Change in the Plasma Renin Activity [ Time Frame: baseline and 24 weeks ]
  • Change in the Serum Insulin Level [ Time Frame: baseline and 24 weeks ]
Not Provided
Not Provided
 
Shiga Microalbuminuria Reduction Trial-2
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hypertension
  • 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.
  • Active Comparator: Direct renin inhibitor
    Intervention: Drug: Aliskiren
  • Active Comparator: Angiotensin receptor blockers
    Intervention: Drug: any angiotensin receptor blockers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
320
December 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01461499
SMART-2
Yes
Not Provided
Not Provided
Hiroshi Maegawa, Shiga University
Shiga University
Not Provided
Study Chair: Hiroshi Maegawa, M.D. Shiga University of Medical Science
Shiga University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP