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Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

NCT ID: NCT00831415

Last Updated: 2018-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

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The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).

The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

DVS SR

Group Type EXPERIMENTAL

desvenlafaxine succinate sustained release tablets

Intervention Type DRUG

25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Interventions

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desvenlafaxine succinate sustained release tablets

25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Intervention Type DRUG

Other Intervention Names

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DVS-233; Pristiq

Eligibility Criteria

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Inclusion Criteria

* Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Exclusion Criteria

* Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

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

Locations

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Pfizer Investigational Site

Aichi, , Japan

Site Status

Pfizer Investigational Site

Chiba, , Japan

Site Status

Pfizer Investigational Site

Fukuoka, , Japan

Site Status

Pfizer Investigational Site

Fukushima, , Japan

Site Status

Pfizer Investigational Site

Gunma, , Japan

Site Status

Pfizer Investigational Site

Hiroshima, , Japan

Site Status

Pfizer Investigational Site

Hokkaido, , Japan

Site Status

Pfizer Investigational Site

Hyōgo, , Japan

Site Status

Pfizer Investigational Site

Ishikawa, , Japan

Site Status

Pfizer Investigational Site

Kanagawa, , Japan

Site Status

Pfizer Investigational Site

Kumamoto, , Japan

Site Status

Pfizer Investigational Site

Kyoto, , Japan

Site Status

Pfizer Investigational Site

Osaka, , Japan

Site Status

Pfizer Investigational Site

Saga, , Japan

Site Status

Pfizer Investigational Site

Saitama, , Japan

Site Status

Pfizer Investigational Site

Shiga, , Japan

Site Status

Pfizer Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3350

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2061002

Identifier Type: -

Identifier Source: secondary_id

3151A1-3350

Identifier Type: -

Identifier Source: org_study_id

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