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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00605813 |
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 to long time use.
Condition | Intervention | Phase |
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Depression Panic Disorder |
Drug: Sertraline hydrochloride |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Special Investigation of Long Term Use of J Zoloft. |
Estimated Enrollment: | 100 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Sertraline hydrochloride.
Patients taking Sertraline hydrochloride.
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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. |
All the patients 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.
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.
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0501091 |
Study First Received: | January 18, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00605813 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Panic Disorder Depression Anxiety Disorders Mental Disorders |
Sertraline Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |