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See also:

  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of amlodipine
  •  

    IDNT study, 2001

    Treatments

    Studied treatment Amlodipine 10mg/d
    Control treatment placebo

    Patients

    Patients hypertensive patients with nephropathy due to type 2 diabetes
    Inclusion criteria age between 30 and 70 years;type 2 diabetes mellitus; hypertension (systolic blood pressure of more than 135 mm Hg while sitting, a diastolic blood pressure of more than 85 mm Hg while sitting, or documented treatment with antihypertensive agents); proteinuria, with urinary protein excretion of at least 900 mg per 24 hours; serum creatinine between 1.0 and 3.0 mg per deciliter (88 and 265 ìmol per liter) in women and 1.2 and 3.0 mg per deciliter (106 and 265 ìmol per liter) in men.
    Baseline characteristics
    baseline BP 159/87 mmHg 
    Female (%) 32% 
    Age 58.6y 
    prior cardiovascular disease 29% 

    Method and design

    Randomized effectives 567 / 569 (studied vs. control)
    Design Parallel groups
    Blinding Double blind
    Follow-up duration 2·6
    Number of centre 210


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    All cause death

    83 / 567
    93 / 569
    0,90 [0,68;1,18]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 83 / 567 (14,6%) 93 / 569 (16,3%) 0,90 [0,68;1,18]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 14,64% 16,34% -17,1‰


    Reference(s)

    Trials register # NA
    • Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.. N Engl J Med 2001;345:851-60
      Pubmed | Hubmed | Fulltext

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