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Last Updated: March 7, 2021

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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 Not yet recruiting 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ramelteon

Condition Name

Condition Name for Ramelteon
Intervention Trials
Insomnia 17
Chronic Insomnia 13
Bipolar Disorder 5
Delirium 5
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Condition MeSH

Condition MeSH for Ramelteon
Intervention Trials
Sleep Initiation and Maintenance Disorders 37
Disease 13
Parasomnias 6
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 448
Mexico 11
Japan 7
Canada 7
Russian Federation 5
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Trials by US State

Trials by US State for Ramelteon
Location Trials
California 25
Ohio 22
Florida 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 26
Phase 3 21
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Ramelteon
Clinical Trial Phase Trials
Completed 40
Terminated 13
Not yet recruiting 11
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Clinical Trial Sponsors for Ramelteon

Sponsor Name

Sponsor Name for Ramelteon
Sponsor Trials
Takeda 44
Takeda Pharmaceuticals North America, Inc. 5
Massachusetts General Hospital 3
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Sponsor Type

Sponsor Type for Ramelteon
Sponsor Trials
Industry 51
Other 45
NIH 4
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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
McKesson
Baxter
Johnson and Johnson
Medtronic

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