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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

Tracking Information
First Submitted Date  ICMJE October 19, 2011
First Posted Date  ICMJE October 28, 2011
Results First Submitted Date  ICMJE November 11, 2016
Results First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
Reduction in Albuminuria [ Time Frame: baseline and 24 weeks ]
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01461499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shiga Microalbuminuria Reduction Trial-2
Official Title  ICMJE Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Hypertension
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Direct renin inhibitor
    Intervention: Drug: Aliskiren
  • Active Comparator: Angiotensin receptor blockers
    Intervention: Drug: any angiotensin receptor blockers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
237
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2011)
320
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461499
Other Study ID Numbers  ICMJE SMART-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hiroshi Maegawa, Shiga University
Study Sponsor  ICMJE Shiga University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hiroshi Maegawa, M.D. Shiga University of Medical Science
PRS Account Shiga University
Verification Date August 2017

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