Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 4:30 AM
Study NCT ID:
NCT00654459
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2008-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-02-24', 'releaseDate': '2009-01-28'}, {'resetDate': '2009-09-24', 'releaseDate': '2009-08-19'}, {'resetDate': '2010-06-28', 'releaseDate': '2010-05-25'}, {'resetDate': '2010-07-26', 'releaseDate': '2010-06-28'}, {'resetDate': '2011-07-20', 'releaseDate': '2011-06-24'}], 'estimatedResultsFirstSubmitDate': '2009-01-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080710', 'term': 'policosanol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2008-04-02', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.\n\nThe aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'males and females aged between 18 and 70 with hypercholesterolemya', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged between 18 and 70\n* Total cholesterol levels \\> 220 mg/dl and LDL-Cholesterol \\> 130 mg/dl;\n* Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months\n\nExclusion Criteria:\n\n* Proven intolerance to an Armolipid Plus compound\n* Pregnant women, and women planning to conceive\n* Patients in therapy with lipid lowering drugs within the previous 6 weeks\n* Triglycerides concentration \\> 500mg/dl were excluded.'}, 'identificationModule': {'nctId': 'NCT00654459', 'briefTitle': 'Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function', 'orgStudyIdInfo': {'id': 'ARM 02-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo']}, {'label': 'B', 'interventionNames': ['Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo']}], 'interventions': [{'name': 'Mixture of Berberine, Policosanol, Red Yeast, Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Armolipid Plus'], 'description': 'A tablet one a day for 6 weeks', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Department of internal medicine University Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Serafino Fazio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rottapharm', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Serafino Fazio MD', 'oldOrganization': 'Federico II University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-01-28', 'type': 'RELEASE'}, {'date': '2009-02-24', 'type': 'RESET'}, {'date': '2009-08-19', 'type': 'RELEASE'}, {'date': '2009-09-24', 'type': 'RESET'}, {'date': '2010-05-25', 'type': 'RELEASE'}, {'date': '2010-06-28', 'type': 'RESET'}, {'date': '2010-06-28', 'type': 'RELEASE'}, {'date': '2010-07-26', 'type': 'RESET'}, {'date': '2011-06-24', 'type': 'RELEASE'}, {'date': '2011-07-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Federico II University (Serafino Fazio MD)'}}}}