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

Daiichi Sankyo

Status and phase: Withdrawn; Phase 2

Conditions: Pulmonary Embolism

Treatments: Drug: Placebo; Drug: DS-9231

Study type: Interventional

Funder types: Industry

Identifiers

NCT03316729

DS9231-A-U201

2017-000552-25 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

DS-9231

Experimental group

Description:

In conjunction with standard of care, participants will receive an intravenous infusion delivering DS-9231 at ascending dose levels in Cohort 1, 2, and 3

Treatment:

Drug: DS-9231

Placebo

Placebo Comparator group

Description:

In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator

Treatment:

Drug: Placebo