DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

• Status: Withdrawn
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo, Inc.

Criteria

Inclusion Criteria:

• Had protocol-defined pulmonary embolism (PE)

• Has stable systolic blood pressure (SBP) >90 mm Hg

• Has evidence of right ventricular (RV) dysfunction

• Has executed informed consent

Exclusion Criteria:

• Has history or plans for thrombotic therapy outside protocol allowance

• Has other contraindications for participation

• Has laboratory results outside protocol-specified limits

• Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives

• Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise:

1. the safety or well-being of the participant or the participant's offspring

2. the safety of study staff

3. the analysis of results