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大うつ病性障害(MDD)の治療における323U66 SRの固定用量試験

基本情報

NCT ID
NCT01138007
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
572
治験依頼者名
GlaxoSmithKline

概要

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

対象疾患

Depressive Disorder, Major

介入

323U66 SR 150 mg tablet(DRUG)
323U66 SR 150 mg placebo tablet(DRUG)

依頼者(Sponsor)