The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity

NCT01773733 | Completed Results DMC

• 1 other identifier: PROMOMED-PRIMAVERA
• Study Type: observational
• Target: 98,774
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alimentary Obesity

Outcome Measures

Primary Outcomes (1)

• Body Weight Loss After 3, 6 & 12 Month Treatment

  Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.

  Baseline, after 3, 6 and 12 months of treatment.

Secondary Outcomes (1)

• Percentage of Participants With Adverse Events

  From the 1st day of Reduxine treatment until the end of the treatment

Study Arms (2)

Obese

Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2)

Overweight & risk factors

Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women of 18-65 years old, in the random gender and demographical proportion, with the diagnosed overweight (BMI ≥ 27 and \< 30) and obesity (BMI ≥ 30).

You may qualify if:

• Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated.
• Patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance.
• Signed informed consent form for participation in the program.

You may not qualify if:

• \- Patients under age of 18 or older than 65;
• Current or the history of:
• coronary artery disease (e.g. angina, myocardial infraction);
• congestive heart failure;
• tachycardia;
• peripheral arterial occlusive disease;
• arrythmia;
• Uncontrolled arterial hypertension \>145/90 mm Hg;
• Hypersensitivity to sibutramine or any components of Reduxine®;
• Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks;
• Current use of other central acting weight reducing drugs or their use within the last 2 weeks;
• Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance;
• Severe eating disorder (anorexia nervosa or bulimia);
• Mental disease;
• Gilles de la Tourette syndrome (generalized tics);

Sponsors & Collaborators

• Promomed, LLC: lead

Related Publications (1)

• Dedov I.I., Mel'nichenko G.A., Romantsova T.I. The strategy of obesity management: the results of All-Russian observational program "Primavera". Obesity and metabolism. 2016;13(1):36-44. (In Russ.) https://doi.org/10.14341/omet2016136-44

  RESULT

Related Links

• Obesity and metabolism is peer-reviewed medical journal that publishes articles on the problems of obesity, metabolic disorders, and endocrine diseases

Results Point of Contact

• Title: Prof. Ivan I . Dedov, Director of the Endocrinology Research Centre
• Organization: FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

dedov@endocrincentr.ru

+7 499 124 4300

Study Officials

• Ivan I Dedov, academician

  FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 23, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2023-04