National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina

CompletadoFase 4ClinicalTrials.gov

ID: NCT01097382Tipo: INTERVENTIONALInicio: 1 de mar de 2010Fin estimado: 1 de abr de 2011

Traducción no disponible, mostrando original

Resumen

Primary Objective: 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

Elegibilidad

Edad mínima: 21 YearsSexo: ALL

Criterios de inclusión

Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).
Accepting to participate in the study and signing informed consent

Criterios de exclusión

Pregnancy or breastfeeding.
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.

Intervenciones

drug

ZOLPIDEM

Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily

Ubicaciones

Investigational Site Number 2

Capital Federal, Argentina

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 3

La Plata, Argentina

Patrocinadores

PrincipalSanofi

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