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Belviq Tablet® Post Marketing Surveillance Protocol

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ClinicalTrials.gov Identifier: NCT03741010
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
Post-marketing surveillance of Lorcaserin

Condition or disease
Weight Loss

Detailed Description:
Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Belviq Tablet® Post Marketing Surveillance Protocol
Actual Study Start Date : February 2, 2015
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021



Primary Outcome Measures :
  1. Incidence of adverse event after this drug administration in general medical [ Time Frame: 12 weeks ]

    Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.

    Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.



Secondary Outcome Measures :
  1. The change from baseline to week 12 in the Body Mass Index(BMI) [ Time Frame: 12 weeks ]
    BMI is measured before administration of the drug and within 12 weeks after administration.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
residents of Korea, in real-world practice
Criteria

Inclusion Criteria:

Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.

  1. Obese patients whose body mass index (BMI) is ≧30 kg/m2.
  2. Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)

Exclusion Criteria:

  1. Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
  2. Female patients of childbearing potential and pregnant or lactating women
  3. Patients taking another weight control drug
  4. Patients with the medical history of drug abuse

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03741010     History of Changes
Other Study ID Numbers: ID-BVQ-401
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms