Clinical Trial: A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Multi-centre, Open-label, Randomised Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Sitamaquine Compared With Amphotericin B in the Treatment of

  • AUC(0-)
  • Cmax
  • time to maximum concentration (tmax)accumulation ratio for sitamaquine.


    • Current Secondary Outcome: 1. Safety parameters; adverse events, 12-lead ECG, echocardiography, vital signs, safety laboratory parameters 2. Initial parasitological cure (28 days) 3. Final parasitological cure (6 months) 4. PK parameter terminal half-life (t1/2) for sitamaquine

    Original Secondary Outcome:

    • Safety parameters; adverse events, 12-lead ECG, echocardiography, vital signs, safety laboratory parameters
    • Initial parasitological cure (28 days)
    • Final parasitological cure (6 months)
    • PK parameter terminal half-life (t1/2) for sitamaquine


    Information By: GlaxoSmithKline

    Dates:
    Date Received: September 26, 2006
    Date Started: August 2006
    Date Completion:
    Last Updated: May 31, 2012
    Last Verified: February 2011