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Related trials

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See also:

  • All hypertension clinical trials
  • All clinical trials of renin inhibitor
  • All clinical trials of aliskiren
  •  

    Schmieder (vs HCTZ) study, 2009

    Treatments

    Studied treatment aliskiren 300 mg
    Control treatment hydrochlorothiazide 25 mg

    Patients

    Patients patients with essential hypertension

    Method and design

    Randomized effectives 567 / 557 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 20 weeks
    Primary endpoint BP reduction


    Results

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

    any adverse event

    369 / 566
    343 / 558
    1,06 [0,97;1,16]

    Adverse events leading to treatment discontinuation

    29 / 566
    41 / 558
    0,70 [0,44;1,11]

    Serious adverse event

    26 / 566
    22 / 558
    classic 1,17 [0,67;2,03]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Serious adverse event 26 / 566 (4,6%) 22 / 558 (3,9%) 1,17 [0,67;2,03]   10614 
    Adverse events leading to treatment discontinuation 29 / 566 (5,1%) 41 / 558 (7,3%) 0,70 [0,44;1,11]   10614 
    any adverse event 369 / 566 (65,2%) 343 / 558 (61,5%) 1,06 [0,97;1,16]   10614 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10614: Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen HLong-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide.Circulation 2009;119:417-25

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Serious adverse event 4,59% 3,94% 6,5‰
    Adverse events leading to treatment discontinuation 5,12% 7,35% -22,2‰
    any adverse event 65,19% 61,47% 3,7%


    Reference(s)

    Trials register # NA
    • Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide.. Circulation 2009;119:417-25
      Pubmed | Hubmed | Fulltext

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