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These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling.

Drug Details

Company Name Business Partner Drug Name Generic Name Unique ID Studied Indications or Disease Phase Approved Drug Label
Pfizer Inc. Zoloft sertraline NCT00150306 Post-Traumatic Stress Disorder In Children and Adolescents Phase III http://media.pfizer.com/files/products/uspi_zoloft.pdf
Clinical Study Summary Protocol No. A0501061: A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD).

This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.

Link to ClinicalTrials.gov registration: http://clinicaltrials.gov/show/NCT00150306


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Company Study
Protocol No. A0501061
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