Genetic-Disease Outcome Consortium-Aliskiren Study

Genetic-Disease Outcome Consortium-Aliskiren Study - G-DOC-ALIS Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005612

Enrollment

100

Registered

2011-05-17

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension with Diabetes Mellitus

Interventions

Aliskiren arm: Administer aliskiren on top of maximum dose of ARB with target blood pressure of 130/80 mmHg (total 24 weeks). Start with 150mg aliskiren daily and dose up to 300mg. In the case of insu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hypertensives with diabetes mellitus with UACR 50-500 mg/gCr

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Reduction rate of urinary albumin/creatinine ratio (UACR) from baseline after 24 weeks	—

Secondary

Measure	Time frame
Remission rate: subjects rate obtaining UACR < 30 mg/gCr Regression rate: subjects rate obtaining UACR &#8804; 50% of baseline	—

Countries

Japan

Contacts

Public ContactTadashi Konoshita

Fukui University School of Medicine Third Department of Internal Medicine

konosita@u-fukui.ac.jp0776-61-8353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026