The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- St. Leonards
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment postcode(s) [6] 0 0
- 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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Boulogne Sur Mer
Country [17] 0 0
France
State/province [17] 0 0
Colmar
Country [18] 0 0
France
State/province [18] 0 0
Grenoble Cedex 9
Country [19] 0 0
France
State/province [19] 0 0
Pessac
Country [20] 0 0
France
State/province [20] 0 0
Strasbourg
Country [21] 0 0
Germany
State/province [21] 0 0
Aschaffenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Bad Mergentheim
Country [23] 0 0
Germany
State/province [23] 0 0
Gottingen
Country [24] 0 0
Germany
State/province [24] 0 0
Halle
Country [25] 0 0
Germany
State/province [25] 0 0
Kunzing
Country [26] 0 0
Germany
State/province [26] 0 0
Munchen
Country [27] 0 0
Germany
State/province [27] 0 0
Ornbau
Country [28] 0 0
Germany
State/province [28] 0 0
Vellmar
Country [29] 0 0
Germany
State/province [29] 0 0
Villingen-Schwenningen
Country [30] 0 0
Israel
State/province [30] 0 0
Ashkelon
Country [31] 0 0
Israel
State/province [31] 0 0
Beer Sheva
Country [32] 0 0
Israel
State/province [32] 0 0
Hadera
Country [33] 0 0
Israel
State/province [33] 0 0
Holon
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Israel
State/province [35] 0 0
Kfar Saba
Country [36] 0 0
Israel
State/province [36] 0 0
Kiryat Biyalik
Country [37] 0 0
Israel
State/province [37] 0 0
Nazaret
Country [38] 0 0
Israel
State/province [38] 0 0
Ramat-Gan
Country [39] 0 0
Israel
State/province [39] 0 0
Rehovot
Country [40] 0 0
Israel
State/province [40] 0 0
Tel Aviv
Country [41] 0 0
Israel
State/province [41] 0 0
Zerifin
Country [42] 0 0
Italy
State/province [42] 0 0
Chieri
Country [43] 0 0
Italy
State/province [43] 0 0
Genova
Country [44] 0 0
Italy
State/province [44] 0 0
Lecco
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
Country [46] 0 0
Italy
State/province [46] 0 0
Rimini
Country [47] 0 0
Italy
State/province [47] 0 0
Rome
Country [48] 0 0
Italy
State/province [48] 0 0
San Benedetto del Tronto
Country [49] 0 0
Latvia
State/province [49] 0 0
Daugavpils
Country [50] 0 0
Latvia
State/province [50] 0 0
Riga
Country [51] 0 0
Lithuania
State/province [51] 0 0
Kaunas
Country [52] 0 0
Lithuania
State/province [52] 0 0
Klaipeda
Country [53] 0 0
Lithuania
State/province [53] 0 0
Panevezys
Country [54] 0 0
Lithuania
State/province [54] 0 0
Siauliai
Country [55] 0 0
Lithuania
State/province [55] 0 0
Vilnius
Country [56] 0 0
Mexico
State/province [56] 0 0
Distrito Federal
Country [57] 0 0
Mexico
State/province [57] 0 0
Jalisco
Country [58] 0 0
Mexico
State/province [58] 0 0
Michioacan
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo Leon
Country [60] 0 0
Mexico
State/province [60] 0 0
San Lis Potosi
Country [61] 0 0
Mexico
State/province [61] 0 0
Aguascalientes
Country [62] 0 0
Netherlands
State/province [62] 0 0
Amsterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Blaricum
Country [64] 0 0
Netherlands
State/province [64] 0 0
Eindhoven
Country [65] 0 0
Netherlands
State/province [65] 0 0
Groningen
Country [66] 0 0
Netherlands
State/province [66] 0 0
Stadskanaal
Country [67] 0 0
Netherlands
State/province [67] 0 0
Zeist
Country [68] 0 0
Netherlands
State/province [68] 0 0
Zwolle
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
Country [70] 0 0
Russian Federation
State/province [70] 0 0
St. Petersburg
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Jerez De La Frontera
Country [73] 0 0
Spain
State/province [73] 0 0
Las Palmas De G. C.
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Marbella
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Cleveland
Country [77] 0 0
United Kingdom
State/province [77] 0 0
County Durham
Country [78] 0 0
United Kingdom
State/province [78] 0 0
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/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
Other publications