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

Phase 1

• Conditions: Albuminuria in hypertensive subjects at increased cardiovascular risk.; Classification code 10001580

• Registration Number: EUCTR2004-000022-75-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-11-09
• Study Start: 2006-07-10
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 615

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 < 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

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) 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
permitted.
10) Immunosuppressant medication use is prohibited during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified