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Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

Last updated on November 13, 2019

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Study Location
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

- Post menopausal women subjects with Osteoporosis who has no experience of use of
Bazedoxifene.

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

- Subject with present or past venous thromboembolism such as deep venous thrombosis,
pulmonary embolism, or retinal venous thrombosis

- Subject in long-term immovability (postoperative recovery, long-term bed rest)

- Subject with antiphospholipid antibody syndrome

NCT01470326
Pfizer
Completed
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief TitleViviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleViviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Brief SummaryIn this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
Detailed DescriptionAll the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.
ConditionOsteoporosis
InterventionDrug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
Study Groups/CohortsBazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
Intervention: Drug: Bazedoxifene
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: March 13, 2018)
3187
Original Estimated Enrollment
 (submitted: November 9, 2011)
3300
Actual Study Completion DateJune 2016
Actual Primary Completion DateJune 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.

Exclusion Criteria:

  • Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis
  • Subject in long-term immovability (postoperative recovery, long-term bed rest)
  • Subject with antiphospholipid antibody syndrome
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 CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01470326
Other Study ID NumbersB1781007
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 DateMarch 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]

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