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

Last updated on May 9, 2018

FOR MORE INFORMATION
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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Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
In 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.
All 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.
Osteoporosis
Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
Intervention: Drug: Bazedoxifene
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3185
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01470326
B1781007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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