A Phase 3 interventional study of Fondaparinux 2.5mg or placebo in Thrombosis, Venous, sponsored by GlaxoSmithKline. Completed at 227 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-06.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 11 studies in Venous Thrombosis by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Venous Thrombosis · GlaxoSmithKline.
Among the 11 studies in Venous Thrombosis by GlaxoSmithKline, this one is one of 2 that started in 2007, is one of 6 in phase 3, and was the 5th registered.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
Browse Venous Thrombosis studies →None of the 11 studies in Venous Thrombosis by GlaxoSmithKline is open now. The open studies under Venous Thrombosis, anywhere →
Of the 84 Venous Thrombosis studies recruiting now, 59 (70%) set no upper age limit and 9 (11%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2007.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,002 is above the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Median enrollment 423 across the 8 interventional studies, 4,068 across the 3 observational. Of the 11 that completed or were terminated, 7 (64%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Venous Thrombosis by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Fondaparinux 2.5mg or placebo
Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up 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.
Time frame: Baseline to Day 47
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up 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.
Time frame: Baseline to Day 77
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 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.
Time frame: Days 47 and 77
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
The number of participants requiring surgery was measured.
Time frame: Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 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.
Time frame: Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 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.
Time frame: Days 47 (or last dose plus 4 days) and 77
Number of Any Adjudicated Bleeding Events at Days 47 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.
Time frame: Days 47 (or last dose plus 4 days) and 77
| Milestone | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Started | 1502 | 1500 |
| Completed | 1481 | 1467 |
| Not completed | 21 | 33 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 9 | 18 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Withdrew: Did not meet eligibility criteria | 1 | 0 |
| Withdrew: Noncompliance | 2 | 1 |
| Withdrew: Other | 3 | 4 |
| Withdrew: Physician decision | 0 | 4 |
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.
| participants | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 | 13 | 88 |
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.
| participants | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77 | 18 | 94 |
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.
| participants | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Participants with at least one event, D 47 | 13 | 88 |
| Death, D 47 | 2 | 1 |
| Symptomatic PE, D 47 | 0 | 5 |
| Symptomatic DVT, D 47 | 3 | 18 |
| Symptomatic recurrence of SVT, D 47 | 5 | 24 |
| Symptomatic extension of SVT, D 47 | 4 | 51 |
| Participants with at least one event, D 77 | 18 | 94 |
| Death, D 77 | 2 | 1 |
| Symptomatic PE, D 77 | 0 | 6 |
| Symptomatic DVT, D 77 | 4 | 19 |
| Symptomatic recurrence of SVT, D 77 | 8 | 26 |
| Symptomatic extension of SVT, D 77 | 5 | 54 |
The number of participants requiring surgery was measured.
| participants | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Day 47 | 11 | 57 |
| Day 77 | 15 | 61 |
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.
| events | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Major bleeding events, Day 47 | 1 | 1 |
| Deaths, Day 47 | 2 | 1 |
| Major bleeding events, Day 77 | 1 | 1 |
| Deaths, Day 77 | 2 | 1 |
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.
| events | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Day 47 | 5 | 8 |
| Day 77 | 6 | 9 |
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.
| events | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Day 47 | 15 | 14 |
| Day 77 | 16 | 15 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fondaparinux 2.5 mg | — | 10/1,499 (0.7%) | 95/1,499 (6.3%) |
| Placebo | — | 16/1,488 (1.1%) | 79/1,488 (5.3%) |
| Event | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| Coronary artery diseaseCardiac disorders | 0/1499 | 2/1488 |
| Angina pectorisCardiac disorders | 0/1499 | 1/1488 |
| Atrial fibrillationCardiac disorders | 0/1499 | 1/1488 |
| Cardiac failure acuteCardiac disorders | 0/1499 | 1/1488 |
| Myocardial infarctionCardiac disorders | 0/1499 | 1/1488 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/1499 | 1/1488 |
| Intestinal obstructionGastrointestinal disorders | 0/1499 | 1/1488 |
| Billiary colicHepatobiliary disorders | 0/1499 | 1/1488 |
| CholelithiasisHepatobiliary disorders | 0/1499 | 1/1488 |
| ErysipelasInfections and infestations | 0/1499 | 1/1488 |
| Event | Fondaparinux 2.5 mg | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 34/1499 | 31/1488 |
| Injection site hematomaSkin and subcutaneous tissue disorders | 27/1499 | 17/1488 |
| HypertensionVascular disorders | 20/1499 | 15/1488 |
| AstheniaGeneral disorders | 14/1499 | 16/1488 |
| Age, Continuous(years) | Fondaparinux 2.5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 57.1 ± 13.29 | 56.9 ± 13.56 | 57.0 ± 13.43 |
| Sex: Female, Male(Participants) | Fondaparinux 2.5 mg | Placebo | Total |
|---|---|---|---|
| Female | 974 | 944 | 1918 |
| Male | 528 | 556 | 1084 |
| Race/Ethnicity, Customized(participants) | Fondaparinux 2.5 mg | Placebo | Total |
|---|---|---|---|
| White, European Heritage | 1485 | 1492 | 2977 |
| Arabic/North African Heritage | 15 | 4 | 19 |
| African American Heritage | 0 | 2 | 2 |
| Asian/South Asian Heritage | 0 | 1 | 1 |
| Mixed Race | 1 | 0 | 1 |
| Missing | 1 | 1 | 2 |
Showing the first 100 of 227 sites across 17 countries. Choose a country and city above to see the rest.
The record gives a start of Mar 2007, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2010, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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