Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function

NCT03158792 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-09-11

No results posted yet for this study

Summary

This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.

Conditions

  • Venous Thromboembolism
  • Renal Impairment

Interventions

DRUG

Enoxaparin 20Mg/0.2mL Prefilled Syringe

Enoxaparin 20mg subcutaneously once daily

DRUG

Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml

Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered

Sponsors & Collaborators

  • Lebanese American University

    lead OTHER

Principal Investigators

  • Nibal R Chamoun, PharmD · Lebanese American University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-24
Primary Completion
2017-07-13
Completion
2017-07-13

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158792 on ClinicalTrials.gov