drugset / Trial / NCT01452763

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

NCT01452763

Phase 3 Completed 621 enrolled Takeda
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Timeline

Start
2011-10
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 15 mg Oral
Subject Vonoprazan Other / unclassified 10 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral