Trial · NCT00443053

Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

NCT00443053, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-08-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis). Trials, record NCT00443053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443053

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
NCT number: NCT00443053
Status: Completed
Phases: Phase 3
Enrollment: 3,002 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Thrombosis, Venous
Interventions: Fondaparinux 2.5mg or placebo
First posted: 2007-03-05
Last updated: 2017-03-06
Results first posted: 2010-08-02

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	Baseline to Day 47	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Secondary	Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	Baseline to Day 77	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Secondary	Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Days 47 and 77	VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within \<=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.
Secondary	Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77	Days 47 and 77	The number of participants requiring surgery was measured.
Secondary	Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin \>=20 g/L (1.24 mmol/L); (3) led to a transfusion of \>=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Secondary	Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Secondary	Number of Any Adjudicated Bleeding Events at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	Baseline to Day 47	Intent-to-Treat (ITT) Population: all randomized participants	participants	NUMBER
SECONDARY	Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	Baseline to Day 77	ITT Population	participants	NUMBER
SECONDARY	Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Days 47 and 77	ITT Population	participants	NUMBER
SECONDARY	Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77	Days 47 and 77	ITT Population	participants	NUMBER
SECONDARY	Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received	events	NUMBER
SECONDARY	Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	As-Treated Population	events	NUMBER
SECONDARY	Number of Any Adjudicated Bleeding Events at Days 47 and 77	Days 47 (or last dose plus 4 days) and 77	As-Treated Population	events	NUMBER

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	Fondaparinux 2.5 mg		13	participants
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	Placebo		88	participants
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	Fondaparinux 2.5 mg		18	participants
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	Placebo		94	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Fondaparinux 2.5 mg	Participants with at least one event, D 47	13	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Placebo	Participants with at least one event, D 47	88	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Fondaparinux 2.5 mg	Death, D 47	2	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Placebo	Death, D 47	1	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Fondaparinux 2.5 mg	Symptomatic PE, D 47	0	participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	Placebo	Symptomatic PE, D 47	5	participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fondaparinux 2.5 mg	1,502
Overall Study	STARTED	Placebo	1,500
Overall Study	COMPLETED	Fondaparinux 2.5 mg	1,481
Overall Study	COMPLETED	Placebo	1,467
Overall Study	NOT COMPLETED	Fondaparinux 2.5 mg	21
Overall Study	NOT COMPLETED	Placebo	33

Source ClinicalTrials.gov

Adverse events80

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
other	Headache	Nervous system disorders	Fondaparinux 2.5 mg	34	1,499
other	Headache	Nervous system disorders	Placebo	31	1,488
other	Injection site hematoma	Skin and subcutaneous tissue disorders	Fondaparinux 2.5 mg	27	1,499
other	Injection site hematoma	Skin and subcutaneous tissue disorders	Placebo	17	1,488
other	Hypertension	Vascular disorders	Fondaparinux 2.5 mg	20	1,499
other	Hypertension	Vascular disorders	Placebo	15	1,488
other	Asthenia	General disorders	Fondaparinux 2.5 mg	14	1,499
other	Asthenia	General disorders	Placebo	16	1,488
serious	Angina pectoris	Cardiac disorders	Fondaparinux 2.5 mg	0	1,499
serious	Angina pectoris	Cardiac disorders	Placebo	1	1,488

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fondaparinux 2.5 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Fondaparinux 2.5 mg	95	1,499
Total, other adverse events	Placebo	79	1,488
Total, serious adverse events	Fondaparinux 2.5 mg	10	1,499
Total, serious adverse events	Placebo	16	1,488

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20860504	DERIVED	PubMed
23821661	DERIVED	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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fondaparinux 2.5 mg vs Placebo: Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	Trial comparisons
Fondaparinux 2.5 mg vs Placebo: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	Trial comparisons
Fondaparinux 2.5 mg vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00443053

GET https://conductscience.org/api/trials/v1/NCT00443053/results?page=2

API reference For AI assistants