CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
sugammadexdrug
Likely dose
sugammadex 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00702715
NCT00702715Phase 3Completed
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A Multi-center, Parallel-group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of 4.0 mg/kg Sugammadex Administered at 1-2 PTC in Subjects With Normal or Severely Impaired Renal Function

Merck Sharp & Dohme LLC·interventional·Posted Jun 20, 2008·Updated May 16, 2017

In Brief

A Phase 3 clinical trial evaluating sugammadex for Anesthesia. Completed, enrolled 69 participants.

Detailed Summary

The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2008
Enrollment StartSep 24, 2008
Primary CompletionMar 15, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.0 years ago

Interventions

sugammadexdrug

Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1 - 0.2 mg.kg-1 rocuronium may be given. In case of maintenance dosing, the target depth of neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.