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Special Investigation Of J Zoloft For Panic Disorder Patients

Last updated on November 12, 2019

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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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Descriptive Information
Brief TitleSpecial Investigation Of J Zoloft For Panic Disorder Patients
Official TitleSpecial Investigation Of J Zoloft For Panic Disorder Patients
Brief SummaryThe 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.
Detailed DescriptionAll 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.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients to whom an investigator involved in A0501092 prescribes sertraline hydrochloride.
ConditionPanic Disorder
InterventionDrug: 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
Study Groups/CohortsSertraline hydrochloride.
The patients of Panic disorder taking Sertraline hydrochloride.
Intervention: Drug: Sertraline hydrochloride
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 10, 2011)
997
Original Estimated Enrollment
 (submitted: January 30, 2008)
1000
Actual Study Completion DateSeptember 2011
Actual Primary Completion DateSeptember 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00605917
Other Study ID NumbersA0501092
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2012

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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