Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) (VIOLINE)
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2011 | ||||
| Last Updated Date | May 6, 2013 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | July 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01470326 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) | ||||
| Official Title ICMJE | Viviant Osteoporosis Long Term Treatment In Post Menopausal Women (VIOLINE) | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets. |
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| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day. |
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| Study Group/Cohort (s) | Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
Intervention: Drug: Bazedoxifene |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 3300 | ||||
| Estimated Completion Date | July 2016 | ||||
| Estimated Primary Completion Date | July 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01470326 | ||||
| Other Study ID Numbers ICMJE | B1781007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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