Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095290
First received: November 2, 2004
Last updated: April 7, 2011
Last verified: September 2008
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 92 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 10, 2014