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

NCT ID: NCT03316729

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Embolism

Keywords

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Sub-massive acute pulmonary embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DS-9231

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

Group Type EXPERIMENTAL

DS-9231

Intervention Type DRUG

DS-9231 in saline solution for intravenous infusion

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is matching saline solution for intravenous infusion

Interventions

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DS-9231

DS-9231 in saline solution for intravenous infusion

Intervention Type DRUG

Placebo

Placebo is matching saline solution for intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Investigational product Matching placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Other Identifiers

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2017-000552-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DS9231-A-U201

Identifier Type: -

Identifier Source: org_study_id