Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Cardiovascular Disease

In brief

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

Key facts

Study ID

NCT00549757

Run by

Novartis Pharmaceuticals

People needed

8606

Starts

2007-10-01

Expected to finish

2013-02-01

Last updated by the study team

2014-04-21

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes and at least one of the following:
• Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
• Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2)
• A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2)
• 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.

You may not qualify if…

• 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)
• EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:
• Aliskiren or aliskiren containing fixed combination products must not be used
• Other protocol-defined inclusion/exclusion criteria applied

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Huntsville, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Montgomery, Alabama, United States
• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Peoria, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Fayetteville, Arkansas, United States
• Novartis Investigative Site — Burlingame, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Oakland, California, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Spring Valley, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Bridgeport, Connecticut, United States
• Novartis Investigative Site — Aventura, Florida, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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