PHASE 2, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, 4-WEEK INPATIENT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO FIXED DOSES OF PF-02545920 COMPARED TO PLACEBO IN THE TREATMENT OF ACU...

Update Il y a 4 ans
Reference: EUCTR2010-020764-38

PHASE 2, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, 4-WEEK INPATIENT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO FIXED DOSES OF PF-02545920 COMPARED TO PLACEBO IN THE TREATMENT OF ACUTE EXACERBATION OF SCHIZOPHRENIA USING RISPERIDONE AS AN ACTIVE CONTROL

Woman and Man

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Extract

•To evaluate the efficacy of PF-02545920 in the treatment of acute exacerbation of schizophrenia during a 4-week double-blind treatment period using the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms from baseline compared to placebo. •To evaluate the safety and tolerability of two fixed dose regimens of PF-02545920 in the treatment of acute exacerbation of schizophrenia. •To evaluate the incidence rate of dystonia associated with two doses of PF-02545920 compared to placebo in the treatment of acute schizophrenia.


Inclusion criteria

  • Schizophrenia

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