Clinical trial NCT01773733: The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alimentary Obesity
Lead sponsor: Promomed, LLC
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 98774
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Body Weight Loss After 3, 6 & 12 Month Treatment
timeFrame: Baseline, after 3, 6 and 12 months of treatment.
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: From the 1st day of Reduxine treatment until the end of the treatment
Other outcomes:
Locations:
Study officials:
affiliation: FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA
name: Ivan I Dedov, academician
role: STUDY_CHAIR
References:
citation: 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