Recent Updates
Recently added Catalysts

Dexmedetomidine, midazolam; fentanyl

Phase 2

Intubated and Mechanically Ventilated Pediatric Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 13, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00652028Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics SubjectsPHASE2 COMPLETED 69 — — Nov 1, 2008Apr 1, 2010Apr 13, 20179 United States, Guatemala
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.

Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine

Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)
≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.

Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine

Observed Peak Plasma Concentration
≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.

Observed peak plasma concentration (Cmax) for Dexmedetomidine

Terminal Elimination Half-life (t1/2)
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.

Terminal elimination half-life (t1/2) for Dexmedetomidine

Plasma Concentration at Steady State (Css)
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.

Plasma concentration at steady state (Css) for Dexmedetomidine

Volume of Steady State Distribution (Vss)
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.

Volume of steady state distribution (Vss) for Dexmedetomidine

Clearance (CL)
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.

Clearance (CL) for Dexmedetomidine

Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score
Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.

RSS Score range from 1 to 6: 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, orientated and tranquil. 3. Patient responds to command only. 4. Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response to stimulus.

Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)
During the treatment period (Approximately 24 hours)

Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period

Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1OTHERDose level 1
Group 2OTHERDose level 2
Group 3OTHERDose level 3
Group 4OTHERDose level 4
Interventions
NameTypeDescription
Dexmedetomidine, midazolam; fentanylDRUGDexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
Unlock Study Design Details
Eligibility Criteria
Age Range2 Years — 16 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous intravenous sedation. * Age: subjects must fit into one of the following age ranges at screening: * ≥2 years old through...

Countries:United StatesGuatemala
Unlock Eligibility Criteria