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Trial record 1 of 1 for:    NCT01470326
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Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) (VIOLINE)

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ClinicalTrials.gov Identifier: NCT01470326
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 9, 2011
First Posted Date November 11, 2011
Results First Submitted Date August 8, 2017
Results First Posted Date November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date November 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2018)
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.
  • Number of Participants With Any Fracture [ Time Frame: 3 years ]
    Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
Original Primary Outcome Measures
 (submitted: November 9, 2011)
  • The frequency of treatment related adverse events. [ Time Frame: 3 years ]
  • Occurrence of all fracture. [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures
 (submitted: March 13, 2018)
  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician.
  • Number of Participants With Treatment-Related Adverse Events by Age [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Smoking Status [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Use of Steroid [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication [ Time Frame: 3 years ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
Original Secondary Outcome Measures
 (submitted: November 9, 2011)
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 3 years ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
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.
Condition Osteoporosis
Intervention Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
Study Groups/Cohorts Bazedoxifene 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 Status Completed
Actual Enrollment
 (submitted: March 13, 2018)
3187
Original Estimated Enrollment
 (submitted: November 9, 2011)
3300
Actual Study Completion Date June 2016
Actual Primary Completion Date June 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01470326
Other Study ID Numbers B1781007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2018