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January 1, 2005Thrombosis and Haemostasis

Pharmacodynamic markers in the early clinical assessment of otamixaban, a direct factor Xa inhibitor

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Key result

No clinical study data or findings were provided in the text, which consists only of journal editorial board information.

Why the study?

Does otamixaban alter pharmacodynamic markers of anti-coagulation in healthy male subjects?

Population

Healthy male subjects (n=80, 10 consecutive parallel groups)

Comparison

Otamixaban via escalating intravenous doses as… vs Placebo (2 subjects per group)

Design

Other

Authors

MOMarie‐Laure OzouxSanofi (France)VCValeria ChuSanofi (United States)KSKelly SimcoxSanofi (United States)

Discussion

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Member takes

Implication

No study data provided; leaves otamixaban PD effects in healthy subjects unaddressed.

Structured PICO

Does otamixaban alter pharmacodynamic markers of anti-coagulation in healthy male subjects?

P
Population
Healthy male subjects (n=80, 10 consecutive parallel groups)
I
Intervention
Otamixaban via escalating intravenous doses as 6-hour infusions (1.7 to 183 microg/kg/h) or bolus dose (30 or 120 microg/kg) with a 6-hour infusion (60 or 140 microg/kg/h)
C
Comparator
Placebo (2 subjects per group)
O
Outcome
Pharmacodynamic markers of anti-coagulation (anti-FXa activity, aPTT, PT, HCT, RVVT, and ETP)surrogate

In a first-in-man study, the novel direct Factor Xa inhibitor otamixaban demonstrated predictable, dose-dependent pharmacodynamic effects on coagulation markers and was well tolerated.

Cite This Study

Ozoux et al. (2005) studied this question. No clinical study data or findings were provided in the text, which consists only of journal editorial board information.

synapsesocial.com/papers/6a20ad74ac4c2e2edfeb8558https://doi.org/10.1160/th05-05-0347
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Also Consider

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