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Trial record 1 of 1 for:    NCT01793142
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Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

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ClinicalTrials.gov Identifier: NCT01793142
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 13, 2013
First Posted Date February 15, 2013
Results First Submitted Date May 31, 2018
Results First Posted Date December 24, 2018
Last Update Posted Date December 24, 2018
Actual Study Start Date October 24, 2013
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2018)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
  • Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs [ Time Frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.
Original Primary Outcome Measures
 (submitted: February 14, 2013)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT01793142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 31, 2018)
  • Overall Efficacy Evaluation of Viviant 20 mg Tablet [ Time Frame: Baseline up to 3 months ]
    Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
  • Number of Participants With Osteoporosis Related Fractures [ Time Frame: Baseline up to 3 months ]
  • Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) [ Time Frame: Baseline up to 3 months ]
    DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
  • Number of Participants With Abnormal X-ray Result [ Time Frame: Baseline up to 3 months ]
    Criteria for abnormality was based on investigator's discretion.
  • Number of Participants With Abnormal Bone Mineral Density Result [ Time Frame: Baseline up to 3 months ]
    A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
  • Number of Participants With Abnormal Biochemical Markers of Bone Turnover [ Time Frame: Baseline up to 3 months ]
    In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
Original Secondary Outcome Measures
 (submitted: February 14, 2013)
event of osteoporosis [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
Official Title Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
Brief Summary This 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 Description continuous enrollment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Postmenopausal osteoporosis and osteopenia patients
Condition Osteoporosis
Intervention Drug: Viviant
Viviant (Bazedoxifene) 20mg once daily
Study Groups/Cohorts Viviant 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 Status Completed
Actual Enrollment
 (submitted: May 31, 2018)
3430
Original Estimated Enrollment
 (submitted: February 14, 2013)
3000
Actual Study Completion Date May 31, 2017
Actual Primary Completion Date May 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries Austria
 
Administrative Information
NCT Number NCT01793142
Other Study ID Numbers B1781047
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 May 2018