A clinical trial to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality

• Conditions: Type 2 diabetes mellitusCardiovascular diseaseMicro-albuminuriaMacro-albuminuriaReduced estimated glomerular filtration rate; MedDRA version: 14.1Level: PTClassification code 10027525Term: MicroalbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10018358Term: Glomerular filtration rate decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2007-000860-25-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-21
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8600

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

Other protocol-defined inclusion/exclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3977
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4295

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 antihypertensive 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)
- Specific to the safety follow-up period: Aliskiren or aliskiren-containing fixed combination products must not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) in patients with diabetes.
- Specific to the safety follow-up period: Participation in another clinical trial, whether or not on investigational drug

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified