Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)

NCT ID: NCT02958527

Last Updated: 2023-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-03

Study Completion Date

2020-05-11

Brief Summary

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SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE

Detailed Description

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This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.

Conditions

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Depression/Depressed State

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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venlafaxine

Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first

venlafaxine

Intervention Type DRUG

The usual adult starting dosage for oral use is 37.5 mg of venlafaxine once daily, which is increased to 75 mg once daily after a meal from 1 week later. The dose may be adjusted within a range not exceeding 225 mg/day according to the patient's age and symptoms. However, the dose should be increased by 75 mg/day at intervals of not less than 1 week.

Interventions

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venlafaxine

The usual adult starting dosage for oral use is 37.5 mg of venlafaxine once daily, which is increased to 75 mg once daily after a meal from 1 week later. The dose may be adjusted within a range not exceeding 225 mg/day according to the patient's age and symptoms. However, the dose should be increased by 75 mg/day at intervals of not less than 1 week.

Intervention Type DRUG

Other Intervention Names

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Effexor

Eligibility Criteria

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Inclusion Criteria

* Patients with no experience of using this product who will be administered this product for the first time
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B2411278

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Other Identifiers

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B2411278

Identifier Type: -

Identifier Source: org_study_id

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