Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
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| ClinicalTrials.gov Identifier: NCT00095290 |
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Recruitment Status :
Completed
First Posted : November 3, 2004
Last Update Posted : April 15, 2011
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Albuminuria | Drug: Ramipril + Irbesartan Drug: Ramipril + Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | September 2004 |
| Actual Primary Completion Date : | November 2005 |
| Actual Study Completion Date : | November 2005 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: A1 |
Drug: Ramipril + Irbesartan
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
Other Name: Avapro |
| Placebo Comparator: A2 |
Drug: Ramipril + Placebo
Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks. |
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
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must be willing and able to provide written informed consent.
- Males and Females 55 years of age and over
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095290
Locations
Show 92 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00095290 |
| Other Study ID Numbers: |
CV131-169 |
| First Posted: | November 3, 2004 Key Record Dates |
| Last Update Posted: | April 15, 2011 |
| Last Verified: | September 2008 |
Keywords provided by Bristol-Myers Squibb:
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Albuminuria Hypertension Elevated Cardiovascular Risk Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk |
Additional relevant MeSH terms:
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Albuminuria Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Ramipril Irbesartan |
Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |