Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Sanofi-Aventis
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00095290

Purpose

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	Intervention	Phase
Albuminuria	Drug: Ramipril + Irbesartan Drug: Ramipril + Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Urine and Urination

Drug Information available for: Ramipril Irbesartan

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment:	400
Study Start Date:	September 2004
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
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
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095290

Show 92 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Sanofi-Aventis

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Aug 1.

ClinicalTrials.gov Identifier:	NCT00095290 History of Changes
Other Study ID Numbers:	CV131-169
Study First Received:	November 2, 2004
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Albuminuria
Hypertension
Elevated Cardiovascular Risk
Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

Additional relevant MeSH terms:

Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ramipril
Irbesartan
Angiotensin-Converting Enzyme Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012