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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00095290




Registration number
NCT00095290
Ethics application status
Date submitted
2/11/2004
Date registered
3/11/2004
Date last updated
15/04/2011

Titles & IDs
Public title
Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
Scientific 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
Secondary ID [1] 0 0
CV131-169
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Albuminuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ramipril + Irbesartan
Treatment: Drugs - Ramipril + Placebo

Experimental: A1 -

Placebo Comparator: A2 -


Treatment: Drugs: Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.

Treatment: Drugs: Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in AER from baseline to Week 20
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Burwood
Recruitment hospital [2] 0 0
Local Institution - Camperdown
Recruitment hospital [3] 0 0
Local Institution - Gosford
Recruitment hospital [4] 0 0
Local Institution - St. Leonards
Recruitment hospital [5] 0 0
Local Institution - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - Box Hill
Recruitment hospital [7] 0 0
Local Institution - Fitzroy
Recruitment hospital [8] 0 0
Local Institution - Parkville
Recruitment hospital [9] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
- Burwood
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- Camperdown
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- Gosford
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- St. Leonards
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- Woolloongabba
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- Box Hill
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment postcode(s) [9] 0 0
- Fremantle
Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Wisconsin
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Alberta
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British Columbia
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Nova Scotia
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Ontario
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Quebec
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France
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Colmar
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France
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France
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Pessac
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Nazaret
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Amsterdam
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Blaricum
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Eindhoven
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Zeist
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Zwolle
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Madrid
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Marbella
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Cleveland
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County Durham
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United Kingdom
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00095290
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00095290