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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00605813
Other study ID # A0501091
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2007
Est. completion date September 2011

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 542
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Baseline up to 52 weeks
Primary Number of Participants of Treatment Related Adverse Events (TRAEs) All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Baseline up to 52 weeks
Secondary Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor Baseline up to 52 weeks
Secondary Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor Baseline up to 52 weeks
Secondary Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor Baseline up to 52 weeks
Secondary Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor Baseline up to 52 weeks
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