Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

Description

This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.

Study Start Date

September, 01 2016

Estimated Completion Date

January 2019

Interventions

  • Drug: placebo
  • Drug: DS-1040b

Study ID

Daiichi Sankyo, Inc. -- DS1040-B-U107

Status

Recruiting

Trial ID

NCT02923115

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

132

Sponsor

Daiichi Sankyo, Inc.

Inclusion Criteria

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned
  • Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization
  • Subjects should be in otherwise satisfactory health in the opinion of the Investigator
  • Subjects must be able to provide written informed consent.

Exclusion Criteria

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation
  • Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned
  • Subjects with PE lesions only in the sub-segmental or smaller arteries
  • Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization
  • Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding
  • Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban
  • Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding
  • Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection)
  • Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (33)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Site Coordinator 617-726-0153 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Site Coordinator 617-726-0153 None
Jacobi Medical Center - The Bronx, New York 176.6 miles Site Coordinator 718-918-5349 None
Jacobi Medical Center - The Bronx, New York 176.6 miles Site Coordinator 718-918-5349 None
NYU Radiology Associate - New York, New York 186.5 miles Site Coordinator 212-263-4434 None
NYU Radiology Associate - New York, New York 186.5 miles Site Coordinator 212-263-4434 None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Capital Area Research - Camp Hill, Pennsylvania 336.7 miles Site Coordinator 717-963-8389 None
Capital Area Research - Camp Hill, Pennsylvania 336.7 miles Site Coordinator 717-963-8389 None
Capital Area Research - Camp Hill, Pennsylvania 336.7 miles Site Coordinator 717-963-8389 None
The Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Site Coordinator 216-445-8108 dolneyd@ccf.org
The Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Site Coordinator 216-445-8108 dolneyd@ccf.org
The Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Site Coordinator 216-445-8108 dolneyd@ccf.org
Duke University Medical Center DUMC - Durham, North Carolina 609.0 miles Site Coordinator 919-668-1770 None
Duke University Medical Center DUMC - Durham, North Carolina 609.0 miles Site Coordinator 919-668-1770 None
Duke University Medical Center DUMC - Durham, North Carolina 609.0 miles Site Coordinator 919-668-1770 None
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Site Coordinator 859-323-8516 v.bulkley@uky.edu
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Site Coordinator 859-323-8516 v.bulkley@uky.edu
Medical University of South Carolina MUSC - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina MUSC - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina MUSC - Charleston, South Carolina 821.2 miles None None None
Northwestern Memorial Hospital - Chicago, Illinois 847.9 miles Site Coordinator 312-695-3264 droshevs@nm.org
Northwestern Memorial Hospital - Chicago, Illinois 847.9 miles Site Coordinator 312-695-3264 droshevs@nm.org
Intercoastal Medical Group - Sarasota, Florida 1,225.8 miles Site Coordinator 941-404-4390 emartinez@intercoastalmedical.com
Intercoastal Medical Group - Sarasota, Florida 1,225.8 miles Site Coordinator 941-404-4390 emartinez@intercoastalmedical.com
Pulmonary Associates of Mobile - Mobile, Alabama 1,244.2 miles Site Coordinator 251-633-0573 mhemphill@lungmds.com
Pulmonary Associates of Mobile - Mobile, Alabama 1,244.2 miles Site Coordinator 251-633-0573 mhemphill@lungmds.com
Mercury Street Medical - Butte, Montana 2,049.8 miles Site Coordinator 406-723-1375 None
Mercury Street Medical - Butte, Montana 2,049.8 miles Site Coordinator 406-723-1375 None
CedarsSinai Medical Center - Beverly Hills, California 2,601.9 miles Site Coordinator 310-423-4765 None
CedarsSinai Medical Center - Beverly Hills, California 2,601.9 miles Site Coordinator 310-423-4765 None
CedarsSinai Medical Center - Beverly Hills, California 2,601.9 miles Site Coordinator 310-423-4765 None

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