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NCT01937767

A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU

Completed Phase 2 Last updated 15 January 2020
What this trial tests

Phase 2 trial testing Remimazolam in General Anesthesia in 90 participants. Completed in 19 February 2014.

Timeline
1 August 2013
Primary endpoint
1 February 2014
19 February 2014

Quick facts

Lead sponsorPaion UK Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment90
Start date1 August 2013
Primary completion1 February 2014
Estimated completion19 February 2014
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Paion UK Ltd. — full company profile →

Who can join

18 and older, any sex, with General Anesthesia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent.
    Kilpatrick GJ. · · 2021 · cited 190× · PMID 34354587 · DOI 10.3389/fphar.2021.690875

Verify or expand the search:

Other trials of Remimazolam

Trials testing the same drug.

Other recruiting trials for General Anesthesia

Currently open trials in the same condition.

Other Paion UK Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01937767.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing