Trial · NCT01662908
A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis
NCT01662908, Phase 2, Completed, Daiichi Sankyo; results first posted 2017-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis. Trials, record NCT01662908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01662908
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis
- NCT number
- NCT01662908
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Deep Vein Thrombosis, Venous Thrombosis
- Interventions
- edoxaban tosylate, enoxaparin/unfractionated heparin, warfarin
- First posted
- 2012-08-13
- Last updated
- 2019-02-26
- Results first posted
- 2017-05-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] | Baseline to final visit (Day 14-21) | Thrombus Volume (mm\^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated |
| Secondary | Number of Participants With Clinically Relevant Bleeding | Initial dose of study drug up to 3 days after last dose | Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding |
| Secondary | Number of Participants With Recurrence of Venous Thromboembolism (VTE) | Baseline to final visit (Day 14-21) | Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive) |
| Secondary | Number of Participants With Major Adverse Cardiovascular Events (MACE) | Initial dose of study drug up to 3 days after last dose | MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death |
| Secondary | Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel | Baseline to final visit (Day 14-21) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] | Baseline to final visit (Day 14-21) | Modified intention to treat (mITT), defined as intention to treat minus the one patient who did not take the investigational product | percentage of change | MEAN |
| SECONDARY | Number of Participants With Clinically Relevant Bleeding | Initial dose of study drug up to 3 days after last dose | Adjudicated in the mITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrence of Venous Thromboembolism (VTE) | Baseline to final visit (Day 14-21) | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Major Adverse Cardiovascular Events (MACE) | Initial dose of study drug up to 3 days after last dose | Adjudicated confirmed events in the mITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel | Baseline to final visit (Day 14-21) | mITT | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] | Edoxaban | -46.6 | Standard Deviation 45.53 | percentage of change | |
| Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] | Warfarin | -51.4 | Standard Deviation 32.96 | percentage of change | |
| Number of Participants With Clinically Relevant Bleeding | Edoxaban | 3 | Participants | ||
| Number of Participants With Clinically Relevant Bleeding | Warfarin | 2 | Participants | ||
| Number of Participants With Recurrence of Venous Thromboembolism (VTE) | Edoxaban | 4 | Participants | ||
| Number of Participants With Recurrence of Venous Thromboembolism (VTE) | Warfarin | 2 | Participants | ||
| Number of Participants With Major Adverse Cardiovascular Events (MACE) | Edoxaban | 2 | Participants | ||
| Number of Participants With Major Adverse Cardiovascular Events (MACE) | Warfarin | 0 | Participants | ||
| Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel | Edoxaban | 0 | Participants | ||
| Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel | Warfarin | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Edoxaban | 56 | |
| Overall Study | STARTED | Warfarin | 28 | |
| Overall Study | COMPLETED | Edoxaban | 50 | |
| Overall Study | COMPLETED | Warfarin | 23 | |
| Overall Study | NOT COMPLETED | Edoxaban | 6 | |
| Overall Study | NOT COMPLETED | Warfarin | 5 |
Source ClinicalTrials.gov
Adverse events236
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | Infections and infestations | Edoxaban | 3 | 56 | |
| other | Urinary Tract Infection | Infections and infestations | Warfarin | 2 | 28 | |
| other | Upper respiratory tract infection | Infections and infestations | Edoxaban | 2 | 56 | |
| other | Upper respiratory tract infection | Infections and infestations | Warfarin | 1 | 28 | |
| other | Clostridium difficile colitis | Infections and infestations | Edoxaban | 1 | 56 | |
| other | Clostridium difficile colitis | Infections and infestations | Warfarin | 0 | 28 | |
| other | Gastroenteritis | Infections and infestations | Edoxaban | 1 | 56 | |
| other | Gastroenteritis | Infections and infestations | Warfarin | 0 | 28 | |
| other | Infected skin ulcer | Infections and infestations | Edoxaban | 1 | 56 | |
| other | Infected skin ulcer | Infections and infestations | Warfarin | 0 | 28 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edoxaban | ||
| Total, all-cause mortality | Warfarin | ||
| Total, other adverse events | Edoxaban | 32 | 56 |
| Total, other adverse events | Warfarin | 17 | 28 |
| Total, serious adverse events | Edoxaban | 4 | 56 |
| Total, serious adverse events | Warfarin | 4 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27165711 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Edoxaban vs Warfarin: Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel | Trial comparisons |
| Edoxaban vs Warfarin: Number of Participants With Major Adverse Cardiovascular Events (MACE) | Trial comparisons |
| Edoxaban vs Warfarin: Number of Participants With Clinically Relevant Bleeding | Trial comparisons |
| Edoxaban vs Warfarin: Number of Participants With Recurrence of Venous Thromboembolism (VTE) | Trial comparisons |
| Edoxaban vs Warfarin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01662908
GET https://conductscience.org/api/trials/v1/NCT01662908/events?page=2