Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
237 participants
INTERVENTIONAL
2011-10-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Direct renin inhibitor
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.
Angiotensin receptor blockers
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Shiga University
OTHER
Responsible Party
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Hiroshi Maegawa
Professor of Medicine
Principal Investigators
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Hiroshi Maegawa, M.D.
Role: STUDY_CHAIR
Shiga University of Medical Science
Locations
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Shiga University of Medical Science
Ōtsu, Shiga, Japan
Countries
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Other Identifiers
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SMART-2
Identifier Type: -
Identifier Source: org_study_id
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