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All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice
The aim of this study is to summarize the data on efficacy and safety of Reduxine administration in the routine clinical practice according to the approved indications.
Secondary objectives: * to study the structure of the population of patients with the diet induced obesity with body mass index (BMI) 30 kg/m2 or diet induced obesity with BMI ≥27 kg/m2 associated with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to determine the areas for further investigations. * to introduce the elements of control of adverse cardiovascular risks into the routine clinical practice: questionnaire concerning enrollment criteria for Reduxine treatment initiation, algorithm of Reduxine administration and treatment efficacy and safety monitoring (assessment schedule). * to assess the effects of the treatment of overweight and obesity with Reduxine on patients' quality of life parameters. The Time Frame: the follow up of the study patients will be performed during six month to one year. Exception - premature discontinuation from the study. The scheduled visits of the patients to the investigational centres are: Week0 (inclusion of the patient), Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and Week 48.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Start Date
November 1, 2012
Primary Completion Date
July 1, 2014
Completion Date
December 1, 2015
Last Updated
January 19, 2024
98,774
ACTUAL participants
Lead Sponsor
Promomed, LLC
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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