NE-58095錠剤の経口投与に関する第II/III相二重盲検並行群間比較試験

基本情報

NCT ID: NCT02063854
ステータス: 完了
試験のフェーズ: 第2/第3相
試験タイプ: 介入
目標被験者数: 871
治験依頼者名: Takeda

概要

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.

対象疾患

Involutional Osteoporosis

介入

NE-58095 DR Placebo(DRUG)

NE-58095 IR(DRUG)

NE-58095 IR Placebo(DRUG)

NE-58095 DR(DRUG)

依頼者（Sponsor）

Ea(INDUSTRY)

武田薬品工業株式会社(INDUSTRY)