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NCT05152303
A Study of Remimazolam Tosilate for Sedation in the ICU
Phase 2 trial testing Remimazolam Tosilate in Sedation in the ICU in 60 participants. Completed in 19 April 2023.
2 April 2023
Quick facts
| Lead sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 12 October 2022 |
| Primary completion | 2 April 2023 |
| Estimated completion | 19 April 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Remimazolam Tosilate — full drug profile →
- Remimazolam Tosilate — full drug profile →
Conditions studied
- Sedation in the ICU — all drugs for Sedation in the ICU →
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):
-
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 -
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:
- PubMed search for NCT05152303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Remimazolam Tosilate
Trials testing the same drug.
- NCT07035301 — Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures · NA · completed
- NCT07467603 — ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients · NA · completed
- NCT06222294 — A Study of Remimazolam Tosilate for Sedation in the ICU · Phase 3 · completed
- NCT06169995 — A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy · Phase 4 · completed
- NCT05913336 — A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU · Phase 1, PHASE2 · completed
Other Fujian Shengdi Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06855147 — Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects · Phase 1 · completed
- NCT06841445 — Efficacy and Safety of HRS9531 Tablet in Obese Subjects · Phase 2 · completed
- NCT06792955 — The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution · Phase 1 · completed
- NCT06723691 — Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healt · Phase 1 · completed
- NCT06732154 — A Phase I Clinical Study of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05152303 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fujian Shengdi Pharmaceutical Co., Ltd.
- Last refreshed: 23 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05152303.
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