Sleep Satisfaction and Psychomotor Performance of Adults
NCT ID: NCT01097382
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2010-03-31
2011-04-30
Brief Summary
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To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration
Secondary Objective:
To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMBIEN CR
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
Interventions
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ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
Eligibility Criteria
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Inclusion Criteria
* Accepting to participate in the study and signing informed consent
Exclusion Criteria
* Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.
* History of substance abuse or dependence (including alcohol) within the past year.
* Hypersensitivity to zolpidem or its excipients.
* Severe hepatic insufficiency
* Severe and/or acute respiratory insufficiency
* Myasthenia gravis.
* OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.
* Severe medical illness.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
21 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 10
Buenos Aires, , Argentina
Investigational Site Number 1
C.a.b.a., , Argentina
Investigational Site Number 4
C.a.b.a., , Argentina
Investigational Site Number 6
C.a.b.a., , Argentina
Investigational Site Number 2
Capital Federal, , Argentina
Investigational Site Number 3
La Plata, , Argentina
Countries
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Other Identifiers
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U1111-1116-9105
Identifier Type: OTHER
Identifier Source: secondary_id
ZOLPI_L_04551
Identifier Type: -
Identifier Source: org_study_id