Albuminuria
Conditions
Keywords
Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
Brief summary
Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
Interventions
DRUGRamipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
DRUGRamipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Sponsors
Sanofi
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be willing and able to provide written informed consent. * Males and Females 55 years of age and over * Subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following: 1. Diabetes 2. Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia 3. Artery disease in the legs, limiting walking capacity and/or blood flow in the legs 4. Stroke occurring more than 3 months prior to the screening visit * All subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit. * All subjects must currently be treated with a class of drugs called ACE inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study. * Women of childbearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends.
Exclusion criteria
* Women who are pregnant or breastfeeding. * Acute systemic febrile/infectious disease or infectious or inflammatory disease of the kidneys * Narrowing of the kidney arteries * Hypotension (low blood pressure) or very high blood pressure * Moderate or Severe Heart Failure * Chronic autoimmune disease * Cancer unless cured or no further treatment needed * Severe kidney failure * Allergy to drugs used in the study: ARBs (candesartan, irbesartan, losartan, telmisartan, valsartan, and/or any other ARB currently or previously in development) and ACE-inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) * Administration of any other investigational drug within 30 days of planned enrollment into the study. * Any circumstances that would prevent coming for study visits or taking study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in AER from baseline to Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in seated systolic and diastolic blood pressures at Week 20; Comparison of change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups | — |
Countries
Australia, Canada, France, Germany, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Russia, Spain, United Kingdom, United States
Outcome results
None listed