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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR RAMELTEON


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505(b)(2) Clinical Trials for Ramelteon

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02840591 ↗ Ramelteon and Citicoline for Delirium Withdrawn University of Texas Southwestern Medical Center Phase 4 2016-07-01 Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ramelteon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00237497 ↗ Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia Completed Takeda Phase 3 2005-07-01 The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
NCT00247390 ↗ Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia. Completed Takeda Phase 3 2005-07-01 The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
NCT00316992 ↗ Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease Completed Takeda Phase 4 2006-04-01 The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
NCT00319215 ↗ Effects of Ramelteon on Driving Ability Completed Takeda Phase 1 2006-03-01 The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
NCT00319215 ↗ Effects of Ramelteon on Driving Ability Completed Utrecht Institute for Pharmaceutical Sciences Phase 1 2006-03-01 The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ramelteon

Condition Name

Condition Name for Ramelteon
Intervention Trials
Insomnia 18
Chronic Insomnia 13
Delirium 6
Bipolar Disorder 5
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Condition MeSH

Condition MeSH for Ramelteon
Intervention Trials
Sleep Initiation and Maintenance Disorders 38
Disease 13
Delirium 7
Sleep Wake Disorders 6
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Clinical Trial Locations for Ramelteon

Trials by Country

Trials by Country for Ramelteon
Location Trials
United States 453
Mexico 11
Japan 10
Canada 7
Russian Federation 5
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Trials by US State

Trials by US State for Ramelteon
Location Trials
California 25
Florida 22
Ohio 22
New York 19
Pennsylvania 18
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Clinical Trial Progress for Ramelteon

Clinical Trial Phase

Clinical Trial Phase for Ramelteon
Clinical Trial Phase Trials
Phase 4 29
Phase 3 21
Phase 2 15
[disabled in preview] 4
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Clinical Trial Status

Clinical Trial Status for Ramelteon
Clinical Trial Phase Trials
Completed 48
Terminated 14
Unknown status 6
[disabled in preview] 7
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Clinical Trial Sponsors for Ramelteon

Sponsor Name

Sponsor Name for Ramelteon
Sponsor Trials
Takeda 44
Takeda Pharmaceuticals North America, Inc. 6
National Institute on Drug Abuse (NIDA) 3
[disabled in preview] 6
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Sponsor Type

Sponsor Type for Ramelteon
Sponsor Trials
Industry 52
Other 51
NIH 7
[disabled in preview] 6
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Harvard Business School
McKinsey
McKesson
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Medtronic

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