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Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR DEXMEDETOMIDINE HYDROCHLORIDE

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Clinical Trials for Dexmedetomidine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00095251 MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status Active, not recruiting Vanderbilt University Medical Center Phase 2 Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
NCT00142493 Effect of Affective Content on Drug Induced Amnesia of Episodic Memory Completed Memorial Sloan Kettering Cancer Center Phase 1 The purpose of this research is to understand how some of the drugs commonly used in anesthesia impair memory. We are particularly interested in whether the emotion associated with a memory influences how well these drugs are able to block memory. We are studying four commonly used drugs—propofol, thiopental, midazolam, and dexmedetomidine, all of which may have slightly differing effects. We will also study an inactive substance, called a placebo, that should have no effect. The results of this study will provide information that will be useful in understanding how memory works, how these drugs affect memory, and possibly why some people don't have their memory blocked as easily as others.
NCT00205712 Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed National Alliance for Research on Schizophrenia and Depression Phase 4 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed Washington University School of Medicine Phase 4 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00216190 A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation Completed Hospira, Inc. Phase 4 The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.
NCT00226785 Dexmedetomidine for Continuous Sedation Terminated Orion Corporation, Orion Pharma Phase 3 The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.
NCT00318955 Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients Completed Maruishi Pharmaceutical Phase 4 The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dexmedetomidine Hydrochloride

Condition Name

Condition Name for Dexmedetomidine Hydrochloride
Intervention Trials
Sedation 37
Delirium 37
Anesthesia 36
Dexmedetomidine 32
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Condition MeSH

Condition MeSH for Dexmedetomidine Hydrochloride
Intervention Trials
Delirium 68
Pain, Postoperative 49
Psychomotor Agitation 17
Heart Diseases 12
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Clinical Trial Locations for Dexmedetomidine Hydrochloride

Trials by Country

Trials by Country for Dexmedetomidine Hydrochloride
Location Trials
United States 315
China 103
Korea, Republic of 83
Egypt 75
Japan 36
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Trials by US State

Trials by US State for Dexmedetomidine Hydrochloride
Location Trials
Ohio 34
Texas 25
Pennsylvania 24
New York 22
Massachusetts 20
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Clinical Trial Progress for Dexmedetomidine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dexmedetomidine Hydrochloride
Clinical Trial Phase Trials
Phase 4 297
Phase 3 70
Phase 2/Phase 3 34
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Clinical Trial Status

Clinical Trial Status for Dexmedetomidine Hydrochloride
Clinical Trial Phase Trials
Completed 276
Recruiting 199
Not yet recruiting 112
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Clinical Trial Sponsors for Dexmedetomidine Hydrochloride

Sponsor Name

Sponsor Name for Dexmedetomidine Hydrochloride
Sponsor Trials
Yonsei University 44
Assiut University 41
Hospira, Inc. 38
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Sponsor Type

Sponsor Type for Dexmedetomidine Hydrochloride
Sponsor Trials
Other 828
Industry 62
NIH 11
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