Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Albuminuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095290
• Other study ID #: CV131-169
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2004
• Last updated: April 7, 2011
• Start date: September 2004
• Est. completion date: November 2005

Study information

• Verified date: September 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria

Intervention

Drug:
• Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
• Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.

Locations

Country	Name	City	State
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Burwood	New South Wales
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Gosford	New South Wales
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	St. Leonards	New South Wales
Australia	Local Institution	Woolloongabba	Queensland
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	Longueuil	Quebec
Canada	Local Institution	Scarborough	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Winnipeg	Manitoba
France	Local Institution	Boulogne Sur Mer
France	Local Institution	Colmar
France	Local Institution	Grenoble Cedex 9
France	Local Institution	Pessac
France	Local Institution	Strasbourg
Germany	Local Institution	Aschaffenburg
Germany	Local Institution	Bad Mergentheim
Germany	Local Institution	Gottingen
Germany	Local Institution	Halle
Germany	Local Institution	Kunzing
Germany	Local Institution	Munchen
Germany	Local Institution	Ornbau
Germany	Local Institution	Vellmar
Germany	Local Institution	Villingen-Schwenningen
Israel	Local Institution	Ashkelon
Israel	Local Institution	Beer Sheva
Israel	Local Institution	Hadera
Israel	Local Institution	Holon
Israel	Local Institution	Jerusalem
Israel	Local Institution	Kfar Saba
Israel	Local Institution	Kiryat Biyalik
Israel	Local Institution	Nazaret
Israel	Local Institution	Ramat-Gan
Israel	Local Institution	Rehovot
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Zerifin
Italy	Local Institution	Chieri
Italy	Local Institution	Genova
Italy	Local Institution	Lecco
Italy	Local Institution	Napoli
Italy	Local Institution	Rimini
Italy	Local Institution	Rome
Italy	Local Institution	San Benedetto del Tronto
Latvia	Local Institution	Daugavpils
Latvia	Local Institution	Riga
Lithuania	Local Institution	Kaunas
Lithuania	Local Institution	Klaipeda
Lithuania	Local Institution	Panevezys
Lithuania	Local Institution	Siauliai
Lithuania	Local Institution	Vilnius
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	San Lis Potosi
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Morelia	Michioacan
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Blaricum
Netherlands	Local Institution	Eindhoven
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Stadskanaal
Netherlands	Local Institution	Zeist
Netherlands	Local Institution	Zwolle
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St. Petersburg
Spain	Local Institution	Barcelona
Spain	Local Institution	Jerez De La Frontera
Spain	Local Institution	Las Palmas De G. C.
Spain	Local Institution	Madrid
Spain	Local Institution	Marbella
United Kingdom	Local Institution	Belfast	County Durham
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Derby	West Midlands
United Kingdom	Local Institution	Middlesborough	Cleveland
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Flushing	New York
United States	Local Institution	Miami	Florida
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	New York	New York
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Providence	Rhode Island
United States	Local Institution	San Antonio	Texas
United States	Local Institution	Tustin	California
United States	Local Institution	W. Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Netherlands,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AER from baseline to Week 20
Secondary	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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm