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
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560 1st Avenue
New York, New York 10016
Phone: 212-263-4434
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185 Cambridge Street
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740 South Limestone Street
Lexington, Kentucky 40536
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Sarasota, Florida 34232
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Beverly Hills, California 90211
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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
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Camp Hill, Pennsylvania 17011
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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
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Phone: 216-445-8108
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Durham, North Carolina 27710
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3 Universitätsplatz
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Mobile, Alabama
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3401 N Broad St
Philadelphia, Pennsylvania
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200 First Street SW
Rochester, Minnesota 55905
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34800 Bob Wilson Drive
San Diego, California 92103
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