Genetic-Disease Outcome Consortium-Aliskiren Study
Phase 4
- Conditions
- Hypertension with Diabetes Mellitus
- Registration Number
- JPRN-UMIN000005612
- Lead Sponsor
- GENOMIC DISEASE OUTCOME CONSORTIUM (G-DOC) STUDY INVESTIGATORS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) HbA1c>9% 2) Serum Kalium>5.2mEq/l 3) eGFR<30ml/min/1.73m2 4) Other trial drugs within 30 days 5) Treated with aldosterone blockers or ARB 6) Acute Heart Failure 7) Chronic liver disease, malignant hypertension, stroke, acute coronary syndrome, acute myocardial infarction, PCI or angioplasty within 3 months 8) Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction rate of urinary albumin/creatinine ratio (UACR) from baseline after 24 weeks
- Secondary Outcome Measures
Name Time Method Remission rate: subjects rate obtaining UACR < 30 mg/gCr Regression rate: subjects rate obtaining UACR &#8804; 50% of baseline