Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
1 other identifier
interventional
400
14 countries
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2004
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 2, 2004
CompletedFirst Posted
Study publicly available on registry
November 3, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedApril 15, 2011
September 1, 2008
1.2 years
November 2, 2004
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in AER from baseline to Week 20
Secondary Outcomes (1)
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
Study Arms (2)
A1
EXPERIMENTALA2
PLACEBO COMPARATORInterventions
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Sanoficollaborator
Study Sites (92)
Local Institution
Tustin, California, United States
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Miami, Florida, United States
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West Palm Beach, Florida, United States
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Chicago, Illinois, United States
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Flushing, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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San Antonio, Texas, United States
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Milwaukee, Wisconsin, United States
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Burwood, New South Wales, Australia
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Camperdown, New South Wales, Australia
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Gosford, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Parkville, Victoria, Australia
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Fremantle, Western Australia, Australia
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Boulogne-sur-Mer, France
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Colmar, France
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Grenoble, France
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Pessac, France
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Strasbourg, France
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Aschaffenburg, Germany
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Bad Mergentheim, Germany
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Göttingen, Germany
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Halle, Germany
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Künzing, Germany
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München, Germany
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Ornbau, Germany
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Vellmar, Germany
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Villingen-Schwenningen, Germany
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Ashkelon, Israel
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Beersheba, Israel
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Hadera, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Kiryat Biyalik, Israel
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Nazareth, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Ẕerifin, Israel
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Chieri, Italy
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Genova, Italy
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Lecco, Italy
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Napoli, Italy
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Rimini, Italy
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Rome, Italy
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San Benedetto del Tronto, Italy
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Daugavpils, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Panevezys, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Monterrey, Nuevo León, Mexico
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México, San Lis Potosi, Mexico
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Stadskanaal, Netherlands
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Zeist, Netherlands
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Zwolle, Netherlands
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Moscow, Russia
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Saint Petersburg, Russia
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Barcelona, Spain
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Jerez de la Frontera, Spain
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Las Palmas de G. C., Spain
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Madrid, Spain
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Marbella, Spain
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Middlesbrough, Cleveland, United Kingdom
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Belfast, County Durham, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Derby, West Midlands, United Kingdom
Related Publications (1)
Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.
PMID: 17667984DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 2004
First Posted
November 3, 2004
Study Start
September 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
April 15, 2011
Record last verified: 2008-09