Albuminuria in hypertensive subjects at increased cardiovascular risk.
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and Females 55 years of age and over. 2) Documented history of Hypertension 3) Subjects with demonstrated albuminuria as measured using a urine dipstick. 4) Subjects with one or more additional cardiovascular risk factors defined as: a) Diabetes b) Advanced coronary artery disease (CAD) defined as previous myocardial infarction (MI), unstable angina, or angina pectoris with a positive stress test or at least two-vessel disease demonstrated on a coronary angiogram. c) Peripheral vascular disease (PVD) - angiographically proven or prior vascular surgery, amputation or intermittent claudication with an ankle/brachial pressure index of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Febrile disease, urinary infection, documented uncontrolled diabetes (HbA1c = 10%), acute glomerulonephritis, excessive exercise or other condition affecting proteinuria. 2) Renovascular disease 3) Systolic blood pressure = 115 mm Hg and or = 200mm Hg and or, a diastolic BP = 115 mm Hg. 4) Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) Class III and IV (see Appendix 2) 5) Renal Insufficiency defined as - creatinine level of = 2.5 mg/dL 6) Hyperkalemia - serum potassium > 5.5 mmol/L 7) Chronic steroid or non-steroidal anti-inflammatory (NSAID) use. Aspirin is permitted. 8) Immunosuppressant medication use is prohibited during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in albumin excretion rate (AER) measured in overnight urine collections from baseline to Week 20 between groups assigned to ramipril and irbesartan or to ramipril and placebo in hypertensive subjects with increased cardiovascular (CV) risk.;Secondary Objective: 1) To estimate the reduction from baseline in seated systolic and diastolic blood pressures at Week 20 within each of the treatment groups. 2) To compare the change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups. 3) To characterize the saftey profiles of each of the two treatment groups.;Primary end point(s): The primary efficacy outcome measure will be defined as the change in AER from baseline to Week 20. Secondary efficacy measures will be the change from baseline in seated systolic and diastolic blood pressures at Week 20. | — |
Countries
Italy, Latvia, Lithuania, Spain
Outcome results
None listed