Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 1:36 PM
Study NCT ID:
NCT01200160
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2010-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carlos.gonzalez@abbott.com', 'phone': '(5255) 5809-', 'title': 'Carlos A Gonzalez MD, PhD', 'phoneExt': '7576', 'organization': 'Abbott Laboratories de México'}, 'certainAgreement': {'otherDetails': 'An agreement is in place that includes a clause of keeping Abbott´s information confidential and that any publication would be performed under agreement with Abbott.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Expected sample size was not achieved due to supply issues with the new formulation in Mexico and the local decision in Colombia to cancel marketing the product in the country.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lipid Abnormalities', 'description': 'Those with the condition and exposed to the study drug', 'otherNumAtRisk': 128, 'otherNumAffected': 31, 'seriousNumAtRisk': 128, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness of Niaspan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDL-Cholesterol'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9755', 'spread': '7.56248', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks regarding baseline visit (visit1)', 'description': 'Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.\n\nCalculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:\n\npercent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))\\*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values', 'timeFrame': 'every 4 to 8 weeks for 24 weeks', 'description': 'Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Flushing Events', 'timeFrame': 'every 4 weeks for 24 weeks', 'description': 'evaluate occurrence of such events over time', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Safety and Tolerability of Niaspan', 'timeFrame': 'every 4 weeks for 24 weeks', 'description': 'Evaluate overall safety of Niaspan through evaluation of adverse events', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lipid Abnormalities', 'description': "No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.\n\nThis study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject's was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.\n\nTypically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lipid Abnormalities'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'There were 128 recruited patients, however for one patient information about birth date is missing, then age is not possible to be calculated. Then descriptive data for "age" is for 127 patients.', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Venezuela', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-To-Treat (ITT) population defined as all enrolled subjects who received at least one dose of study medication'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2010-09-10', 'resultsFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-15', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Niaspan', 'timeFrame': '24 weeks regarding baseline visit (visit1)', 'description': 'Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.\n\nCalculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:\n\npercent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))\\*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.'}], 'secondaryOutcomes': [{'measure': 'Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values', 'timeFrame': 'every 4 to 8 weeks for 24 weeks', 'description': 'Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score'}, {'measure': 'Frequency of Flushing Events', 'timeFrame': 'every 4 weeks for 24 weeks', 'description': 'evaluate occurrence of such events over time'}, {'measure': 'Overall Safety and Tolerability of Niaspan', 'timeFrame': 'every 4 weeks for 24 weeks', 'description': 'Evaluate overall safety of Niaspan through evaluation of adverse events'}]}, 'conditionsModule': {'keywords': ['Low-Density Lipoprotein Cholesterol', 'Hypertriglyceridemia', 'Latin America', 'Cardiovascular Diseases', 'Cholesterol', 'Sedentary Lifestyle', 'High-Density Lipoprotein Cholesterol'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of observation of 12 months. This includes an enrollment period of 6 months in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on Case Report Forms (CRFs) by the investigator or site staffs according to the protocol.", 'detailedDescription': "This is a Post-Marketing Observational study (PMOS) of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of 12 months. This includes an enrollment period of 6 months and a treatment duration in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on CRFs by the investigator or site staffs according to the protocol.\n\nPrior to enrollment in the study, each subject will be required to give their written informed consent to participate in the study. Written informed consent will include a statement authorizing the use and/or disclosure of their personal and/or health data. The subject will be assured that patient confidentiality will be maintained at all times according to the local regulations, and that data that might identify the patient will not be collected\n\nFor patient's consenting to participate in this PMOS study and meeting all of the inclusion and none of the exclusion criteria, at the initial visit or baseline as well at subsequent visits if appropriate , their demographic, medical history, physical examination, vital sign, flushing/adverse event assessments, concomitant medication information, Niaspan dose change/compliance, and lab testing will be documented as per standard medical practice in each country, although not in a protocolized manner.\n\nIf Niaspan® treatment is discontinued, subjects will be followed for another 1 month for any adverse event."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male and female subject \\>18 years-old\n* Subjects with primary hyperlipidemia or mixed dyslipidemia with elevated levels of total cholesterol,, LDL-C (low-density lipoprotein-cholesterol), triglycerides and/or decreased levels of HDL-C (high-density lipoprotein-cholesterol) (\\< 40 mg/dL) and has demonstrated an inadequate response to a lipid-restricted diet and other non-pharmacologic measures alone such as exercise\n* Subject has demonstrated persistent dyslipidemic values and/or inadequate response or intolerance to other pharmacologic therapies such as statins, fibrates, resins, etc.\n* Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device (IUD), birth control pills or barrier device) during and for 3 months after discontinuation of study treatment.\n\nExclusion Criteria\n\n* Subject has been treated with any other investigational product in the last 30 days before the day of the screening visit\n* Subject exhibits signs of acute illness with clinically relevant findings in the pre-study examination\n* Subject has known hypersensitivity to niacin or any component of Niaspan®\n* Subject has significant or unexplained hepatic and/or renal dysfunction\n* Subject has active peptic ulcer disease\n* Subject exhibits active arterial bleeding\n* Subject is pregnant or lactating\n* The mental condition of the subject renders him/her unable to understand the nature, scope, and possible consequences of the study\n* Subject is unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study'}, 'identificationModule': {'nctId': 'NCT01200160', 'briefTitle': 'Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America', 'orgStudyIdInfo': {'id': 'P12-055'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lipid abnormalities', 'description': 'Niacin', 'interventionNames': ['Drug: Niacin']}], 'interventions': [{'name': 'Niacin', 'type': 'DRUG', 'otherNames': ['Niaspan'], 'armGroupLabels': ['Lipid abnormalities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101-102', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Site Reference ID/Investigator# 48183', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Site Reference ID/Investigator# 48182', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '20129', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42108', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '20234', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42110', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '44657', 'city': 'Guadalajara, Jalisco', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42103'}, {'zip': '52140', 'city': 'Metepec, Estado de Mexico', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42105'}, {'zip': 'C.P. 11650', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 26348', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '03920', 'city': 'Mexico City DF', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42102'}, {'zip': '06359', 'city': 'Mexico City DF', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42107'}, {'zip': '11560', 'city': 'Mexico City DF', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42109'}, {'zip': '11850', 'city': 'Mexico City DF', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42106'}, {'zip': '11650', 'city': 'Tijuana, Baja California Norte', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42104', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '22420', 'city': 'Tijuana, Baja California Norte', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42112', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '29000', 'city': 'Tuxtla Gutierrez, Chiapas', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42111'}, {'zip': '29030', 'city': 'Tuxtla Gutierrez, Chiapas', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42114'}, {'zip': '98608', 'city': 'Zacatecas City', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42113', 'geoPoint': {'lat': 22.76843, 'lon': -102.58141}}, {'zip': '45200', 'city': 'Zapopan, Jalisco', 'country': 'Mexico', 'facility': 'Site Reference ID/Investigator# 42115'}, {'zip': '8050', 'city': 'Bolívar', 'country': 'Venezuela', 'facility': 'Site Reference ID/Investigator# 44202', 'geoPoint': {'lat': 11.05259, 'lon': -63.94017}}, {'zip': '1010', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Site Reference ID/Investigator# 26350', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}, {'zip': '1010', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Site Reference ID/Investigator# 44206', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}, {'zip': '1060', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Site Reference ID/Investigator# 44203', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}, {'zip': '2001', 'city': 'Estado Carabobo', 'country': 'Venezuela', 'facility': 'Site Reference ID/Investigator# 44204'}], 'overallOfficials': [{'name': 'Enrique C Morales Villegas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Investigación Cardiometabólica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'QUASY', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}