CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
Dexmedetomidine hydrochloride +1 moredrug
Likely dose
Dexmedetomidine hydrochloride 0.7 mcg/kgfrom 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/NCT01438957
NCT01438957Phase 3Completed
CompareCT.gov

Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care

Pfizer·interventional·Posted Sep 22, 2011·Updated Mar 22, 2021

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine hydrochloride and Placebo for Sedation. Completed, enrolled 119 participants across 12 sites.

Detailed Summary

The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesJapan
CollaboratorsMaruishi Pharmaceutical

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartJun 3, 2011
Primary CompletionNov 18, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.8 years ago

Interventions

Dexmedetomidine hydrochloridedrug

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

Placebodrug