Status:
WITHDRAWN
DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
Lead Sponsor:
Daiichi Sankyo
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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:
- the safety or well-being of the participant or the participant's offspring
- the safety of study staff
- the analysis of results
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03316729
Start Date
January 1 2018
End Date
February 1 2020
Last Update
December 24 2018
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