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NCT02923115 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT02923115: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT02923115 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02923115, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
Clinically relevant bleeding was defined as major or clinically relevant non-major (CRNM) bleeding adjudicated by the Clinical Events Committee (CEC) based on International Society of Thrombosis and Haemostasis (ISTH) definitions and the CEC charter.
Interventions
- DRUG Placebo
- DRUG Enoxaparin
- DRUG DS-1040b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2016-06-23 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 1 |
What the finished NCT02923115 record still lists
NCT02923115 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02923115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02923115 about?
NCT02923115 is a clinical study titled "Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism". 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 embo...
What is the current status of trial NCT02923115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2016-06-23. Estimated completion is 2019-08-05.
What interventions are being tested in trial NCT02923115?
The interventions under investigation include: Placebo (DRUG), Enoxaparin (DRUG), DS-1040b (DRUG).
Who is sponsoring clinical trial NCT02923115?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02923115's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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