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Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Primary Purpose

Albuminuria

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ramipril + Irbesartan
Ramipril + Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Albuminuria focused on measuring Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

Change in AER from baseline to Week 20

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2004
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00095290
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria
Keywords
Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ramipril + Irbesartan
Other Intervention Name(s)
Avapro
Intervention Description
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Ramipril + Placebo
Intervention Description
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Primary Outcome Measure Information:
Title
Change in AER from baseline to Week 20
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: 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
Facility Information:
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Tustin
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California
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United States
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Miami
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W. Palm Beach
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Providence
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Burwood
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Australia
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Camperdown
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Gosford
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Latvia
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Riga
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Guadalajara
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Morelia
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Blaricum
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Jerez De La Frontera
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Spain
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Belfast
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Derby
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United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17667984
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.
Results Reference
derived

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Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

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