CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,272 enrolled
Drug / intervention
Sertraline hydrochloridedrug
Likely dose
Sertraline hydrochloride 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00605865
NCT00605865N/ACompleted
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Drug Use Investigation of Jzoloft.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Jan 31, 2008·Updated Jan 28, 2021

In Brief

An observational study evaluating Sertraline hydrochloride for Panic Disorder and Depression. Completed, enrolled 2,272 participants.

Detailed Summary

The objective of this surveillance 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPanic Disorder, Depression
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2008
Enrollment StartApr 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.4 years ago

Interventions

Sertraline hydrochloridedrug

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 A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration.