Irbesartan Versus Placebo in Combination with Standard Cardiovascular Protection ACE-I Therapy with Ramipril for the Treatment of Albuminuria in Subjects at Elevated Cardiovascular Risk - IMPROVE

Bristol-Myers Squibb International Corporation0 个研究点目标入组 615 人开始时间: 2006年7月10日最近更新: 2021年8月2日

试验速览

暂无简介。

•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 < 0.9.
•d) Cerebrovascular accident (CVA) occurring greater than 3 months prior to the
•screening visit
•5) Subjects currently on a stable dose of ACE-I therapy equivalent to 5 mg or more of
•ramipril for a minimum of 2 months prior to their screening/enrollment visit.
•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

•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) Chronic autoimmune disease
•6) Neoplastic disease unless cured and not requiring further treatment
•7) Renal Insufficiency defined as - creatinine level of = 2.5 mg/dL
•8) Hyperkalemia - serum potassium > 5.5 mmol/L
•9) Chronic steroid or non-steroidal anti-inflammatory (NSAID) use. Aspirin is
•10) Immunosuppressant medication use is prohibited during the study.

发起方