CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
DS-1040b +2 moredrug
Likely dose
Enoxaparin 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02923115
NCT02923115Phase 2Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Oct 4, 2016·Updated Apr 19, 2023

In Brief

A Phase 2 clinical trial evaluating DS-1040b, Placebo, and 1 other intervention for Pulmonary Embolism and Thrombotic Disease. Completed, enrolled 134 participants across 46 sites in 8 countries.

Detailed Summary

This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism, Thrombotic Disease
CountriesAustria, Belgium, France, Germany, Italy, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 4, 2016
Enrollment StartJun 23, 2016
Primary CompletionAug 5, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.7 years ago

Interventions

DS-1040bdrug

Single, continuous intravenous infusion over 12 to 24 hours (depending on cohort)

Placebodrug

Single, continuous intravenous infusion of 0.9% sodium chloride over 12 to 24 hours

Enoxaparindrug

Subcutaneous injection 1 mg/kg twice daily