You are here

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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Inje University Haeundae Paik Hospital
Haeundae-gu, Busan, 48108 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
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

- Postmenopausal osteoporosis and osteopenia patients

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

- Patients with active or past history of venous thromboembolic events including deep
vein thrombosis,

- Patients with pulmonary embolism and retinal vein thrombosis

NCT01793142
Pfizer
Completed
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief TitlePost Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
Official TitlePost Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
Brief SummaryThis 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 Descriptioncontinuous enrollment
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPostmenopausal osteoporosis and osteopenia patients
ConditionOsteoporosis
InterventionDrug: Viviant
Viviant (Bazedoxifene) 20mg once daily
Study Groups/CohortsViviant treatment group
Viviant treatment group
Intervention: Drug: Viviant
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 StatusCompleted
Actual Enrollment
 (submitted: May 31, 2018)
3430
Original Estimated Enrollment
 (submitted: February 14, 2013)
3000
Actual Study Completion DateMay 31, 2017
Actual Primary Completion DateMay 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location CountriesAustria
 
Administrative Information
NCT NumberNCT01793142
Other Study ID NumbersB1781047
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now