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

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression/Depressed State
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 no experience of using this product who will be administered this
product for the first time

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Exclusion criteria are not provided in this study

NCT02958527
Pfizer
Active, not recruiting
Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)

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Descriptive Information
Brief TitleDrug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)
Official TitleDRUG USE INVESTIGATION OF EFFEXOR
Brief SummarySECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
Detailed DescriptionThis 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.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study
ConditionDepression/Depressed State
InterventionDrug: 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.
Other Name: Effexor
Study Groups/Cohortsvenlafaxine
Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first
Intervention: Drug: venlafaxine
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 StatusActive, not recruiting
Estimated Enrollment
 (submitted: February 10, 2017)
1
Original Estimated Enrollment
 (submitted: November 4, 2016)
1200
Estimated Study Completion DateMarch 11, 2020
Estimated Primary Completion DateMarch 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with no experience of using this product who will be administered this product for the first time

Exclusion Criteria:

  • Exclusion criteria are not provided in this study
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 NumberNCT02958527
Other Study ID NumbersB2411278
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2019

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