drugset

drugset / Trial / NCT00671086

Efficacy of Ramelteon in Subjects With Chronic Insomnia

NCT00671086 ↗

Phase 3 Completed 1213 enrolled Takeda

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Timeline

Start: 2003-02
Primary completion: 2004-09
Completion: 2004-09

Publications

Results Richardson GS, Zammit G, Wang-Weigand S, Zhang J. Safety and subjective sleep effects of ramelteon administration in adults and older adults with chronic primary insomnia: a 1-year, open-label study. J Clin Psychiatry. 2009 Apr;70(4):467-76. doi: 10.4088/jcp.07m03834. Epub 2009 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	8 mg	Oral
Subject	Ramelteon	Unknown	16 mg	Oral

Indications