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Special Investigation Of J Zoloft For Panic Disorder Patients

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Show details

Patients with panic disorder need to be taking sertraline hydrochloride in order to be
enrolled in the surveillance.

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

Patients not taking sertraline hydrochloride.

NCT00605917
Pfizer
Completed
Special Investigation Of J Zoloft For Panic Disorder Patients

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Special Investigation Of J Zoloft For Panic Disorder Patients
Special Investigation Of J Zoloft For Panic Disorder Patients
The objective of this surveillance is to collect information for panic disorder patients 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.
All patients with panic disorder to 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 A0501092 prescribes sertraline hydrochloride.
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 A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration.

Other Name: J Zoloft, Zoloft
Sertraline hydrochloride.
The patients of Panic disorder 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
997
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with panic disorder need to be taking sertraline hydrochloride in order to be enrolled in the surveillance.

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
 
 
NCT00605917
A0501092
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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