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Special Investigation Of Long Term Use Of Sertraline.

Last updated on May 10, 2018

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Study Location
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1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Panic Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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The patients who take sertraline hydrochloride for longer than the duration of 16 weeks
among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Patients not taking sertraline hydrochloride.

NCT00605813
Pfizer
Completed
Special Investigation Of Long Term Use Of Sertraline.

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Special Investigation Of Long Term Use Of Sertraline.
Special Investigation Of Long Term Use Of J ZOLOFT.
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.
All the patients for whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.
  • Depression
  • Panic Disorder
Drug: Sertraline hydrochloride

J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.

Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms".

Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration.

Other Name: J Zoloft, Zoloft
Sertraline hydrochloride.
Patients taking Sertraline hydrochloride.
Intervention: Drug: Sertraline hydrochloride
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion Criteria:

Patients not taking sertraline hydrochloride.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00605813
A0501091
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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