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Last Updated: December 6, 2022

CLINICAL TRIALS PROFILE FOR ROZEREM


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505(b)(2) Clinical Trials for Rozerem

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OTC NCT02840591 ↗ Ramelteon and Citicoline for Delirium Withdrawn University of Texas Southwestern Medical Center Phase 4 2016-07-01 Primary aim of this study is to assess the feasibility of conducting clinical research for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 Rozerem

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.
NCT00325728 ↗ Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease Completed Takeda Phase 2 2006-03-21 The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
NCT00337272 ↗ Treating Chronic Insomnia in Breast Cancer Patients Terminated Takeda Pharmaceuticals North America, Inc. Phase 4 2006-08-01 This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
NCT00337272 ↗ Treating Chronic Insomnia in Breast Cancer Patients Terminated Accelerated Community Oncology Research Network Phase 4 2006-08-01 This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rozerem

Condition Name

Condition Name for Rozerem
Intervention Trials
Insomnia 13
Chronic Insomnia 7
Delirium 4
Bipolar Disorder 4
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Condition MeSH

Condition MeSH for Rozerem
Intervention Trials
Sleep Initiation and Maintenance Disorders 24
Disease 10
Delirium 5
Bipolar Disorder 4
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Clinical Trial Locations for Rozerem

Trials by Country

Trials by Country for Rozerem
Location Trials
United States 193
Russian Federation 5
Japan 4
United Kingdom 3
Germany 3
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Trials by US State

Trials by US State for Rozerem
Location Trials
California 13
Ohio 11
Florida 10
New York 9
Texas 8
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Clinical Trial Progress for Rozerem

Clinical Trial Phase

Clinical Trial Phase for Rozerem
Clinical Trial Phase Trials
Phase 4 21
Phase 3 12
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Rozerem
Clinical Trial Phase Trials
Completed 29
Terminated 9
Unknown status 4
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Clinical Trial Sponsors for Rozerem

Sponsor Name

Sponsor Name for Rozerem
Sponsor Trials
Takeda 29
Takeda Pharmaceuticals North America, Inc. 4
Northwestern University 2
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Sponsor Type

Sponsor Type for Rozerem
Sponsor Trials
Industry 33
Other 29
U.S. Fed 4
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Serving leading biopharmaceutical companies globally:

Colorcon
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Mallinckrodt
McKinsey

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