Study Details
A study to evaluate efficacy and safety of zolpidem modified release formulation in insomnia patients
This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Clinicaltrials.gov ID
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
Astellas Study ID
The unique identification code given by the study sponsor.
STCR-0802-TW
EudraCT ID
The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).
N/A
Condition
Sleep Disorder or Early and Middle Insomnia, Insomnia
Phase
These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.
Phase 4
Age
18 Years - 64 Years
Sex
Female & Male
Product
N/A
Type
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
Interventional
Trial Dates
May 2009 - Nov 2010
Masking
None (Open Label)
Enrollment number
42
A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients with Primary Insomnia
Study summary
Study documents
Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.
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