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

November 2, 2004
April 7, 2011
September 2004
November 2005   (final data collection date for primary outcome measure)
Change in AER from baseline to Week 20
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Complete list of historical versions of study NCT00095290 on ClinicalTrials.gov Archive Site
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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Not Provided
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Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Albuminuria
  • Drug: Ramipril + Irbesartan
    Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
    Other Name: Avapro
  • Drug: Ramipril + Placebo
    Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
  • Experimental: A1
    Intervention: Drug: Ramipril + Irbesartan
  • Placebo Comparator: A2
    Intervention: Drug: Ramipril + Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   United States,   Australia,   Canada,   France,   Germany,   United Kingdom,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Russian Federation,   Spain
 
NCT00095290
CV131-169
Not Provided
Not Provided
Bristol-Myers Squibb
Sanofi
Not Provided
Bristol-Myers Squibb
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP