A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
NCT00956319 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2011-10-06
Summary
The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.
Conditions
- Sleep Initiation and Maintenance Disorders
- Primary Insomnia
Interventions
- DRUG
-
Zolpidem MR
oral
- DRUG
-
Estazolam
oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- Taiwan
Study Locations
More Related Trials
-
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
NCT06975514 ·Status: RECRUITING ·Phase: PHASE3
-
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
NCT00352144 ·Status: COMPLETED ·Phase: PHASE3
-
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
NCT00432198 ·Status: COMPLETED ·Phase: PHASE4
-
Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
NCT01710631 ·Status: COMPLETED ·Phase: PHASE3
-
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
NCT00283790 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
NCT00380081 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder
NCT05525637 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
NCT00999219 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
NCT00770510 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
NCT02839200 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
NCT00685269 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
NCT01896336 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Chronic Hypnotic Use 2
NCT02456532 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
NCT05456152 ·Status: UNKNOWN ·Phase: PHASE3
-
Trial of Zolpidem for Sleep in Children With Autism
NCT05540574 ·Status: RECRUITING ·Phase: PHASE2
-
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
NCT00699608 ·Status: COMPLETED ·Phase: PHASE3
-
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
NCT01106859 ·Status: COMPLETED ·Phase: PHASE1
-
Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
NCT00156533 ·Status: COMPLETED ·Phase: PHASE4
-
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
NCT00716521 ·Status: COMPLETED ·Phase: PHASE1
-
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
NCT00374777 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
NCT00368056 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
NCT00425243 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Insomnia in Patients With Low Back Pain
NCT00365976 ·Status: COMPLETED ·Phase: PHASE4
-
Zolpidem's Effects on Road Cycling Performance
NCT06800378 ·Status: COMPLETED ·Phase: PHASE4
-
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
NCT00608985 ·Status: COMPLETED ·Phase: PHASE3