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NCT01793142

Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

Last Updated: 2018-12-24

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

Total Enrollment

3430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-24

Study Completion Date

2017-05-31

Brief Summary

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This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs

Detailed Description

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continuous enrollment

Conditions

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Osteoporosis

Keywords

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Osteoporosis postmenopausal SERM

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Viviant treatment group

Viviant

Intervention Type DRUG

Viviant (Bazedoxifene) 20mg once daily

Interventions

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Viviant

Viviant (Bazedoxifene) 20mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal osteoporosis and osteopenia patients

Exclusion Criteria

* Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
* Patients with pulmonary embolism and retinal vein thrombosis

Eligible Sex

FEMALE

Accepts Healthy Volunteers

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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Inje University Haeundae Paik Hospital

Haeundae-gu, Busan, South Korea

Site Status

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, Capital Metropolitan, South Korea

Site Status

Dankook University Hospital

Cheonan-si, Chuncheongnam-do, South Korea

Site Status

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status