A randomized, double-blind, placebo-controlled, parallel-group study 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
- Diabetes type 2
- Registration Number
- EUCTR2007-000860-25-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8600
For full list, please refer to the protocol
1. Patients with type 2 diabetes according to WHO definition
2. Male or female patients = 35 years of age.
3. Patients who provide written informed consent to participate in the study
after the purpose and nature of the investigation have been clearly explained to
them
4. Patients with at least one of the following :
• Persistent macroalbuminuria (UACR = 200 mg/g [or 22.6 mg/mmol] in at least
two out of three first morning void urine samples)
• Persistent microalbuminuria (UACR = 20 mg/g and < 200 mg/g [or UACR =
2.26 mg/mmol and < 22.6 mg/mmol] in at least two of three morning void
urines) and a mean eGFR < 60 mL/min/1.73m2 calculated by the abbreviated
MDRD study equation (Levey, et al 2000) (mean of two consecutive
measurements)
• A history of cardiovascular disease and a mean eGFR < 60 mL/min/1.73m2
History of cardiovascular disease is defined as at least one of the following:
• Previous MI (previous hospitalization with a discharge diagnosis of MI)
• Previous stroke (previous hospitalization with a discharge diagnosis of
stroke. A previous transient ischemic attack -TIA- is not sufficient to fulfill this
criterion)
• HF (previous hospitalization with a discharge diagnosis of HF, with or without
preserved ejection fraction)
• Coronary artery disease (CAD) defined as follows:
• History of percutaneous coronary intervention [PCI]
• Coronary artery bypass graft [CABG]
• Angiographically proven stenosis = 50% in at least one major epicardial
coronary artery
5. Patient's concomitant treatment must include an ACEI or an ARB. Patient should
be on conventional therapy according to national guidelines. Patients must not
have had any adjustments to their concomitant antihypertensive therapy for at
least four (4) weeks prior to randomization (Visit 3).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
For full list, please refer to the protocol
1. eGFR < 30 mL/min/1.73m2 as calculated by the abbreviated MDRD study
equation (mean of two consecutive measurements).
2. Serum potassium >5.0 mmol/L (at the visit directly preceding Visit 3). If the
investigator has reason to believe the serum potassium result is invalid, one
repeat test may be done.
3. History of any cardiovascular event (stroke, transient ischemic cerebral attack,
MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization
due to HF) during the 3 months prior to Visit 1.
• If a patient experiences such an event between Visit 1 and randomization at
Visit 3, he/she should be withdrawn from the screening phase. If suitable, the
patient can be re-screened at a later stage (see Section 5.2).
4. Hypertension (at Visit 3): any patient with a mean sitting systolic blood pressure
(msSBP) = 135 mmHg or msDBP = 85 mmHg should be excluded unless treated
with at least 3 anti-hypertensive medications; even if treated with 3 or more
anti-hypertensive agents, a patient with msSBP = 170 mmHg or msDBP = 110
mmHg must be excluded.
5. Congestive heart failure NYHA class III or IV.
6. Concomitant treatment with two (2) or more renin-angiotensin-aldosterone
system blocking agents apart from the study drug, e.g. ACEI, ARB or
aldosterone-antagonist or any renin inhibitor.
7. Unstable serum creatinine: defined as = 20% difference between 2 consecutive
serum creatinine measurements before Visit 3. A maximum of 4 measurements
will be allowed. If the difference between the first 2 measurements is = 20% of
the higher value, a third measurement should be performed at the next visit. If
the difference between the last 2 measurements is = 20% of the higher value,
at fourth measurement should be performed at the next visit. If the difference
between the last two measurements performed is = 20%, the patient is
excluded.
8. Second or third degree heart block without a pacemaker.
9. Concurrent potentially life threatening arrhythmia or other uncontrolled
arrhythmia.
10. Clinically significant valvular heart disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method