The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)
|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|