AlbuminuriaPhase 4NCT00095290
Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
A Phase 4 study testing Ramipril + Irbesartan in people with Albuminuria, run by Bristol-Myers Squibb at 92 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Albuminuria
- What is being tested?
- Ramipril + Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 92 sitesin 14 countries
- Study dates
- Sep 2004to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
92 sites in 14 countries.
92 sites in 14 countries
Israel12 sites
Local Institution
Ashkelon
Local Institution
Beersheba
Local Institution
Hadera
Local Institution
Holon
Local Institution
Jerusalem
Local Institution
Kfar Saba
Local Institution
Kiryat Biyalik
Local Institution
Nazareth
Local Institution
Ramat Gan
Local Institution
Rehovot
Local Institution
Tel Aviv
Local Institution
Tsrifin
United States11 sites
Local Institution
Chicago, Illinois
Local Institution
Cleveland, Ohio
Local Institution
Flushing, New York
Local Institution
Miami, Florida
Local Institution
Milwaukee, Wisconsin
Local Institution
New York, New York
Local Institution
Philadelphia, Pennsylvania
Local Institution
Providence, Rhode Island
Local Institution
San Antonio, Texas
Local Institution
Tustin, California
Local Institution
West Palm Beach, Florida
Australia9 sites
Local Institution
Box Hill, Victoria
Local Institution
Burwood, New South Wales
Local Institution
Camperdown, New South Wales
Local Institution
Fitzroy, Victoria
Local Institution
Fremantle, Western Australia
Local Institution
Gosford, New South Wales
Local Institution
Parkville, Victoria
Local Institution
St Leonards, New South Wales
Local Institution
Woolloongabba, Queensland
Germany9 sites
Local Institution
Aschaffenburg
Local Institution
Bad Mergentheim
Local Institution
Göttingen
Local Institution
Halle
Local Institution
Künzing
Local Institution
München
Local Institution
Ornbau
Local Institution
Vellmar
Local Institution
Villingen-Schwenningen
Canada8 sites
Local Institution
Edmonton, Alberta
Local Institution
Halifax, Nova Scotia
Local Institution
Laval, Quebec
Local Institution
Longueuil, Quebec
Local Institution
Scarborough Village, Ontario
Local Institution
Toronto, Ontario
Local Institution
Vancouver, British Columbia
Local Institution
Winnipeg, Manitoba
Italy7 sites
Local Institution
Chieri
Local Institution
Genova
Local Institution
Lecco
Local Institution
Naples
Local Institution
Rimini
Local Institution
Rome
Local Institution
San Benedetto del Tronto
Netherlands7 sites
Local Institution
Amsterdam
Local Institution
Blaricum
Local Institution
Eindhoven
Local Institution
Groningen
Local Institution
Stadskanaal
Local Institution
Zeist
Local Institution
Zwolle
Mexico6 sites
Local Institution
Aguascalientes, Aguascalientes
Local Institution
Guadalajara, Jalisco
Local Institution
México, San Lis Potosi
Local Institution
Mexico City, Mexico City
Local Institution
Monterrey, Nuevo León
Local Institution
Morelia, Michioacan
France5 sites
Local Institution
Boulogne-sur-Mer
Local Institution
Colmar
Local Institution
Grenoble
Local Institution
Pessac
Local Institution
Strasbourg
Lithuania5 sites
Local Institution
Kaunas
Local Institution
Klaipėda
Local Institution
Panevezys
Local Institution
Šiauliai
Local Institution
Vilnius
Spain5 sites
Local Institution
Barcelona
Local Institution
Jerez de la Frontera
Local Institution
Las Palmas de G. C.
Local Institution
Madrid
Local Institution
Marbella
United Kingdom4 sites
Local Institution
Belfast, County Durham
Local Institution
Birmingham, West Midlands
Local Institution
Derby, West Midlands
Local Institution
Middlesbrough, Cleveland
About this study
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
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.
- Conditions
- Albuminuria
- Being tested
- Ramipril + Irbesartan, Ramipril + Placebo
- Keywords
- Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
- Medical subject headings
- Albuminuria, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril + IrbesartanDrug
Also called Avapro
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Ramipril + PlaceboDrug
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Ramipril + Irbesartan |
| A2 | Placebo comparator | Not described Receives: Drug: Ramipril + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AER from baseline to Week 20
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095290
- Sponsor's protocol ID
- CV131-169
- Status last verified
- Sep 2008
- First submitted
- 2 Nov 2004
- Last updated
- 15 Apr 2011
- Results posted
- No
Publications
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.
PubMed 17667984
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00095290
- Acronym / sponsor ID
- CV131-169
- Conditions
- Albuminuria
- Keywords
- Albuminuria, Hypertension, Elevated Cardiovascular Risk, Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Sep 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 3 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Ramipril + Irbesartan |
| A2 | Placebo comparator | Drug: Ramipril + Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril + IrbesartanAlso: AvaproTablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks. | Drug | A1 |
| Ramipril + PlaceboTablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks. | Drug | A2 |
Primary outcome
Change in AER from baseline to Week 20
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
- Derived from this study: PubMed 17667984Bakris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
92 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramipril + Irbesartan in people with Albuminuria, run by Bristol-Myers Squibb at 92 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in Israel, United States, Australia, Germany, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AER from baseline to Week 20. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00095290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.