Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Study Overview
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Brief Summary
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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.

Official Title
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Irbesartan Versus Placebo in Combination With Standard Cardiovascular Protection ACE-I Therapy With Ramipril for the Treatment of Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

Conditions
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Albuminuria

Intervention / Treatment
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* Drug: Ramipril + Irbesartan
* Drug: Ramipril + Placebo


Participation Criteria
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Eligibility Criteria
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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: Diabetes Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia Artery disease in the legs, limiting walking capacity and/or blood flow in the legs 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Ramipril + Irbesartan<br>* Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.<br>* Other names: Avapro;|
| Placebo Comparator: A2<br> | Drug: Ramipril + Placebo<br>* Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AER from baseline to Week 20 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk