NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Patients with type 2 diabetes at high risk for cardiovascular and renal events
Date of first enrollment	09/05/2008
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Aliskiren INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Primary outcomes; Occurrence of cardiovascular and/or renal complications Secondary outcomes; Occurrence of cardiovascular complications, occurrence of renal complications
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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 =< 3 months prior to Visit 1 - Unstable serum creatinine - Hypertension: Mean sitting systolic blood pressure (msSBP) >= 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) >= 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications - Hypertension msSBP >= 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.
Exclude criteria