Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01773733
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dedov@endocrincentr.ru', 'phone': '+7 499 124 4300', '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'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Obese', 'description': 'Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2)', 'otherNumAtRisk': 56643, 'deathsNumAtRisk': 56643, 'otherNumAffected': 2322, 'seriousNumAtRisk': 56643, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Overweight & Risk Factors', 'description': 'Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia', 'otherNumAtRisk': 13167, 'deathsNumAtRisk': 13167, 'otherNumAffected': 540, 'seriousNumAtRisk': 13167, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 906, 'numAffected': 906}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 210, 'numAffected': 210}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 511, 'numAffected': 511}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 119, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'notes': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 453, 'numAffected': 453}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 105, 'numAffected': 105}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension/increased blood pressure', 'notes': 'Hypertension/increased blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 170, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'tachycardia', 'notes': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 114, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'notes': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 170, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Other Adverse Events', 'notes': 'Other Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56643, 'numEvents': 673, 'numAffected': 673}, {'groupId': 'EG001', 'numAtRisk': 13167, 'numEvents': 157, 'numAffected': 157}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Body Weight Loss After 3, 6 & 12 Month Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56643', 'groupId': 'OG000'}, {'value': '13167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obesity', 'description': 'Patients 18-65 y.o. with alimentary obesity BMI (Body Mass Index) ≥ 30 kg/m2'}, {'id': 'OG001', 'title': 'Overweight & Risk Factors', 'description': 'Patients 18-65 y.o. overweight, BMI ≥ 27 kg/m2 plus T2DM (type 2 diabetes mellitus) or dyslipidemia'}], 'classes': [{'title': 'Body weight loss after 3 month treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56643', 'groupId': 'OG000'}, {'value': '13167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'Body weight loss after 6 month treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28565', 'groupId': 'OG000'}, {'value': '12866', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-14.4', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Body weight loss after 12 month treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21622', 'groupId': 'OG000'}, {'value': '4641', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.0', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-19.2', 'spread': '8.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 3, 6 and 12 months of treatment.', 'description': 'Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56643', 'groupId': 'OG000'}, {'value': '13167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obesity', 'description': 'Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2)'}, {'id': 'OG001', 'title': 'Overweight & Risk Factors', 'description': 'Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the 1st day of Reduxine treatment until the end of the treatment', 'description': 'Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Obesity', 'description': 'Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2)'}, {'id': 'FG001', 'title': 'Patients With Overweight Associated With DM2', 'description': 'Patients 18-65 y.o. with DM2 and owerweigt (BMI ≥ 27 kg/m2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80146'}, {'groupId': 'FG001', 'numSubjects': '13167'}]}, {'type': '3 Months of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54841'}, {'groupId': 'FG001', 'numSubjects': '11365'}]}, {'type': '6 Months of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33424'}, {'groupId': 'FG001', 'numSubjects': '8007'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21417'}, {'groupId': 'FG001', 'numSubjects': '4846'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58729'}, {'groupId': 'FG001', 'numSubjects': '8321'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3286'}, {'groupId': 'FG001', 'numSubjects': '540'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other different categories of not compl', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55415'}, {'groupId': 'FG001', 'numSubjects': '7781'}]}]}], 'preAssignmentDetails': '98774 patients signed ICF (Informed Consent Forms), but only 93313 patients started Reduxine treatment, as soon as 5461 patients discontinued prior to the treatment start due to contraindications detected after ICF completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80146', 'groupId': 'BG000'}, {'value': '13167', 'groupId': 'BG001'}, {'value': '93313', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Obesity', 'description': 'Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2)'}, {'id': 'BG001', 'title': 'Patients With Overweight Associated With DM2', 'description': 'Patients 18-65 y.o. with DM2 and overweight (BMI ≥ 27 kg/m2)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80146', 'groupId': 'BG000'}, {'value': '13167', 'groupId': 'BG001'}, {'value': '93313', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80146', 'groupId': 'BG000'}, {'value': '13167', 'groupId': 'BG001'}, {'value': '93313', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56643', 'groupId': 'BG000'}, {'value': '13167', 'groupId': 'BG001'}, {'value': '69810', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46617', 'groupId': 'BG000'}, {'value': '10836', 'groupId': 'BG001'}, {'value': '57453', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10026', 'groupId': 'BG000'}, {'value': '2331', 'groupId': 'BG001'}, {'value': '12357', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98774}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2012-12-20', 'resultsFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-19', 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight Loss After 3, 6 & 12 Month Treatment', 'timeFrame': 'Baseline, after 3, 6 and 12 months of treatment.', 'description': 'Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'From the 1st day of Reduxine treatment until the end of the treatment', 'description': 'Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alimentary Obesity']}, 'referencesModule': {'availIpds': [{'url': 'https://www.omet-endojournals.ru/jour/article/view/7988', 'type': 'published data', 'comment': "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"}], 'references': [{'type': 'RESULT', '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'}], 'seeAlsoLinks': [{'url': 'https://www.omet-endojournals.ru/jour/article/view/7988', 'label': 'Obesity and metabolism is peer-reviewed medical journal that publishes articles on the problems of obesity, metabolic disorders, and endocrine diseases'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Secondary objectives:\n\n* 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.\n* 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).\n* to assess the effects of the treatment of overweight and obesity with Reduxine on patients' quality of life parameters.\n\nThe Time Frame: the follow up of the study patients will be performed during six month to one year. Exception - premature discontinuation from the study.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated.\n* 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.\n* Signed informed consent form for participation in the program.\n\nExclusion Criteria:\n\n\\- Patients under age of 18 or older than 65;\n\nCurrent or the history of:\n\n* coronary artery disease (e.g. angina, myocardial infraction);\n* congestive heart failure;\n* tachycardia;\n* peripheral arterial occlusive disease;\n* arrythmia;\n* Uncontrolled arterial hypertension \\>145/90 mm Hg;\n* Hypersensitivity to sibutramine or any components of Reduxine®;\n* Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks;\n* Current use of other central acting weight reducing drugs or their use within the last 2 weeks;\n* Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance;\n* Severe eating disorder (anorexia nervosa or bulimia);\n* Mental disease;\n* Gilles de la Tourette syndrome (generalized tics);\n* Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes);\n* Organic cause of obesity (e.g. hypothyrosis);\n* Thyrotoxicosis;\n* Sever liver and/or kidney function abnormality;\n* Benign prostatic hyperplasia;\n* Phaeochromocytoma;\n* Narrowangle glaucoma;\n* Documented pharmacologic, drug or alcohol addiction;\n* Pregnancy and lactation;\n* Refusal to sign the informed consent form for participation in the program;\n* Participation in a clinical study of any new drug product within 90 days prior to the screening visit."}, 'identificationModule': {'nctId': 'NCT01773733', 'acronym': 'Primavera', 'briefTitle': 'The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Promomed, LLC'}, 'officialTitle': 'All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'PROMOMED-PRIMAVERA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2)'}, {'label': 'Overweight & risk factors', 'description': 'Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ivan I Dedov, academician', 'role': 'STUDY_CHAIR', 'affiliation': 'FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Promomed, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}