A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers during Long-term Therapy of Low-dose Aspirin.

TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 439 人开始时间: 2011年9月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
•2. Participants who have completed the preceding study
•3. Outpatient (including inpatient for examinations)

•1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
•2. Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
•3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
•4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
•5. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
•6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
•7. Participants with a previous or current history of aspirin-induced asthma

发起方

TAKEDA PHARMACEUTICAL COMPANY LTD.