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

NCT ID: NCT01773733

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98774 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

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.

Detailed Description

Secondary objectives:

• 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.

Conditions

Alimentary Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obese

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

No interventions assigned to this group

Overweight & risk factors

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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);
• Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes);
• Organic cause of obesity (e.g. hypothyrosis);
• Thyrotoxicosis;
• Sever liver and/or kidney function abnormality;
• Benign prostatic hyperplasia;
• Phaeochromocytoma;
• Narrowangle glaucoma;
• Documented pharmacologic, drug or alcohol addiction;
• Pregnancy and lactation;
• Refusal to sign the informed consent form for participation in the program;
• Participation in a clinical study of any new drug product within 90 days prior to the screening visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Promomed, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan I Dedov, academician

Role: STUDY_CHAIR

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

References

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

Reference Type: RESULT

Study Documents

Document Type: published data

The observation program allow to implement the principles of active monitoring of the efficacy and safety of the drug in the current clinical practice and to develop a skill of reasonable prescribing. In Primavera program it was shown that the use of Reduxine® (sibutramine+ microcrystalline cellulose) leads to loss of body weight and doesn't lead to serious adverse effect

View Document

Related Links

https://www.omet-endojournals.ru/jour/article/view/7988

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

Other Identifiers

PROMOMED-PRIMAVERA

Identifier Type: -

Identifier Source: org_study_id