Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Phase 4

Completed

• Conditions: Albuminuria
• Interventions: Drug: Ramipril + Irbesartan; Drug: Ramipril + Placebo

• Registration Number: NCT00095290
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-11-02
• Study First Submitted QC: 2004-11-02
• Study First Posted: 2004-11-03
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2008-09
• Disposition First Submitted: 2010-02-15
• Disposition First Submitted QC: 2010-02-15
• Disposition First Posted: 2010-02-17
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Ramipril + Irbesartan	-
A2	Ramipril + Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in AER from baseline to Week 20

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Derby, West Midlands, United Kingdom