Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
35–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
