Alimentary ObesityPrimaveraNCT01773733
The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
An observational study of Alimentary Obesity, run by Promomed, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alimentary Obesity
- How many people
- 98,774 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 3, 6 and 12 months of treatment.
Secondary outcomes (1)
Percentage of Participants With Adverse Events
Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study
Measured: From the 1st day of Reduxine treatment until the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alimentary ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan I Dedov, academician, Study chair, FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773733
- Sponsor's protocol ID
- PROMOMED-PRIMAVERA
- Acronym
- Primavera
- Status last verified
- Apr 2023
- First submitted
- 20 Dec 2012
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01773733
- Acronym / sponsor ID
- Primavera / PROMOMED-PRIMAVERA
- Conditions
- Alimentary Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98,774 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- Patients under age of 18 or older than 65;
- coronary artery disease (e.g. angina, myocardial infraction);
- congestive heart failure;
- tachycardia;
- peripheral arterial occlusive disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Weight Loss After 3, 6 & 12 Month Treatment
Time frame: Baseline, after 3, 6 and 12 months of treatment.
Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.
1 secondary outcome
Percentage of Participants With Adverse Events
Time frame: From the 1st day of Reduxine treatment until the end of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationDedov 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
- Obesity and metabolism is peer-reviewed medical journal that publishes articles on the problems of obesity, metabolic disorders, and endocrine diseasesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan I Dedov, academician study chair
FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA
Questions about this trial
What is this clinical trial studying?
An observational study of Alimentary Obesity, run by Promomed, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Loss After 3, 6 & 12 Month Treatment (time frame: Baseline, after 3, 6 and 12 months of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.