Clinical trial NCT00095290: Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Albuminuria
Keywords: Albuminuria
Hypertension
Elevated Cardiovascular Risk
Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2004-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in AER from baseline to Week 20
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: W. Palm Beach
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Flushing
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Philadelphia
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facility: Local Institution
state: Pennsylvania
city: Providence
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facility: Local Institution
state: Rhode Island
city: San Antonio
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facility: Local Institution
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city: Burwood
country: Australia
facility: Local Institution
state: New South Wales
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution
state: New South Wales
city: St. Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Box Hill
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facility: Local Institution
state: Victoria
city: Fitzroy
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facility: Local Institution
state: Victoria
city: Parkville
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facility: Local Institution
state: Victoria
city: Fremantle
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state: Western Australia
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city: Vancouver
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facility: Local Institution
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city: Winnipeg
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facility: Local Institution
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city: Scarborough
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city: Toronto
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city: Laval
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city: Longueuil
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state: Quebec
city: Boulogne Sur Mer
country: France
facility: Local Institution
city: Colmar
country: France
facility: Local Institution
city: Grenoble Cedex 9
country: France
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country: France
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city: Strasbourg
country: France
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
city: Bad Mergentheim
country: Germany
facility: Local Institution
city: Gottingen
country: Germany
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city: Halle
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city: Kunzing
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Ornbau
country: Germany
facility: Local Institution
city: Vellmar
country: Germany
facility: Local Institution
city: Villingen-Schwenningen
country: Germany
facility: Local Institution
city: Ashkelon
country: Israel
facility: Local Institution
city: Beer Sheva
country: Israel
facility: Local Institution
city: Hadera
country: Israel
facility: Local Institution
city: Holon
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
facility: Local Institution
city: Kiryat Biyalik
country: Israel
facility: Local Institution
city: Nazaret
country: Israel
facility: Local Institution
city: Ramat-Gan
country: Israel
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Chieri
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Lecco
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: San Benedetto del Tronto
country: Italy
facility: Local Institution
city: Daugavpils
country: Latvia
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Kaunas
country: Lithuania
facility: Local Institution
city: Klaipeda
country: Lithuania
facility: Local Institution
city: Panevezys
country: Lithuania
facility: Local Institution
city: Siauliai
country: Lithuania
facility: Local Institution
city: Vilnius
country: Lithuania
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Mexico
country: Mexico
facility: Local Institution
state: San Lis Potosi
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Blaricum
country: Netherlands
facility: Local Institution
city: Eindhoven
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Stadskanaal
country: Netherlands
facility: Local Institution
city: Zeist
country: Netherlands
facility: Local Institution
city: Zwolle
country: Netherlands
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Jerez De La Frontera
country: Spain
facility: Local Institution
city: Las Palmas De G. C.
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Marbella
country: Spain
facility: Local Institution
city: Middlesborough
country: United Kingdom
facility: Local Institution
state: Cleveland
city: Belfast
country: United Kingdom
facility: Local Institution
state: County Durham
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Derby
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
References:
citation: 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.