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NCT05152303

A Study of Remimazolam Tosilate for Sedation in the ICU

Completed Phase 2 Last updated 23 May 2023
What this trial tests

Phase 2 trial testing Remimazolam Tosilate in Sedation in the ICU in 60 participants. Completed in 19 April 2023.

Timeline
12 October 2022
Primary endpoint
2 April 2023
19 April 2023

Quick facts

Lead sponsorFujian Shengdi Pharmaceutical Co., Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date12 October 2022
Primary completion2 April 2023
Estimated completion19 April 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Sedation in the ICU. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients.
    Liu N, Jiang Z, Nie Y, Zuo L, et al · · 2023 · cited 2× · PMID 36920745 · DOI 10.1007/s12325-023-02456-7
  2. Efficacy and safety of remimazolam tosylate for sedation in ICU patients: A multicenter, randomized, phase 2 study.
    Liu N, Lin F, Wen J, Yu X, et al · · 2026 · PMID 42164575 · DOI 10.1016/j.jointm.2026.01.009

Verify or expand the search:

Other trials of Remimazolam Tosilate

Trials testing the same drug.

Other Fujian Shengdi Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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