The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)
|ClinicalTrials.gov Identifier: NCT01773733|
Recruitment Status : Unknown
Verified August 2014 by Promomed, LLC.
Recruitment status was: Active, not recruiting
First Posted : January 23, 2013
Last Update Posted : August 4, 2014
|Condition or disease|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||100000 participants|
|Official Title:||All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
|BMI ≥ 30|
|BMI ≥27 kg/m2 associated with DM2|
- weight reduction, kg [ Time Frame: Dec 2015 ]
- Heart Rate, bpm [ Time Frame: Dec 2015 ]
- Blood pressure, mmHg [ Time Frame: Dec 2015 ]
- Adverse events [ Time Frame: Dec 2015 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773733
|Moscow, Moscow region, Russian Federation, 299090|