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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:3/23/2019
Start Date:June 23, 2016
End Date:November 30, 2019

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A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism

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.


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.
We found this trial at
16
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-2000
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740 South Limestone Street
Lexington, Kentucky 40536
Phone: 859-323-5259
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Sarasota, Florida 34232
Phone: 941-330-1864
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Beverly Hills, California 90211
Phone: 310-423-4765
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Phone: 718-918-5349
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Butte, Montana 59701
Phone: 406-723-1375
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Camp Hill, Pennsylvania 17011
Phone: 717-963-8389
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Phone: 312-926-2773
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-445-8108
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Durham, North Carolina 27710
Phone: 919-668-1770
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3 Universitätsplatz
Graz, 8010
Phone: +4331638581326
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Mobile, Alabama
Phone: 251-631-3023
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560 1st Avenue
New York, New York 10016
Phone: 212-263-4434
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Phone: 215-707-9527
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-3525
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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34800 Bob Wilson Drive
San Diego, California 92103
Phone: 619-543-1944
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