The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice|
- weight reduction, kg [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]
- Heart Rate, bpm [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
- Blood pressure, mmHg [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|BMI ≥ 30|
|BMI ≥27 kg/m2 associated with DM2|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773733
|Moscow, Moscow region, Russian Federation, 299090|