The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773733
|Moscow, Moscow region, Russian Federation, 299090|