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Phase 3 study of Aliskiren in patients with type 2 diabetes at high risk for cardiovascular and renal events

Phase 3 study of Aliskiren in patients with type 2 diabetes at high risk for cardiovascular and renal events

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220554
Enrollment
Unknown
Registered
2008-05-09
Start date
2008-05-09
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

Patients with type 2 diabetes at high risk for cardiovascular and renal events

Interventions

investigational material(s) Generic name etc : Aliskiren INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : O

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Type 2 diabetes and at least one of the following: -- Macroalbuminuria -- Microalbuminuria and a reduced kidney function -- Previous heart attack and a reduced kidney function -- Previous stroke and a reduced kidney function -- Heart Failure a reduced kidney function -- Coronary artery disease a reduced kidney function - Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both. Exclusion Criteria: - Type 1 diabetes mellitus - Cardiovascular event or procedure == 135 and = 85 and = 170 or msDBP >= 110 mmHg - Baseline Serum Potassium > 5.0 mmol/L - Patients who are treated with two renin-angiotensin-aldosterone-system-blockers - Patients with NYHA class III or IV heart failure - Known renal artery stenosis - Previous randomization into the AVOID trial (CSPP100C2201) Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Primary outcomes; Occurrence of cardiovascular and/or renal complications Secondary outcomes; Occurrence of cardiovascular complications, occurrence of renal complications—

Outcome results

None listed

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