deltatrials
Completed PHASE3 NCT01010022

Trial of 6% HES130/0.4

Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study

Sponsor: Fresenius Kabi Japan

Conditions Hemorrhage Hypovolemia
Interventions 6% hydroxyethyl starch 130/0.4 6% hydroxyethyl starch 70/0.5 (Salinhes®)
Updated 5 times since 2017 Last updated: Mar 9, 2011 Started: Nov 30, 2009 Primary completion: Jul 31, 2010 Completion: Nov 30, 2010

This PHASE3 trial investigates Hemorrhage and Hypovolemia and is currently completed. Fresenius Kabi Japan leads this study, which shows 5 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Nov 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fresenius Kabi Japan
Data source: Fresenius Kabi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Fukuoka, Japan
  • • Kobe, Japan
  • • Okayama, Japan
  • • Osaka, Japan
  • • Sapporo, Japan
  • • Tokyo, Japan