Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01362218
Status:
TERMINATED
Last Update Posted:
2013-04-24
First Post:
2011-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'whyStopped': "Per sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2011-05-26', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.', 'timeFrame': 'Day 56'}], 'secondaryOutcomes': [{'measure': '• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.', 'timeFrame': 'Day 56'}, {'measure': '• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.', 'timeFrame': 'Day 56'}, {'measure': '• Difference in total cholesterol levels between the basal and the final visit of treatment period.', 'timeFrame': 'Day 56'}, {'measure': '• Difference in triglyceride levels between the basal and the final visit of treatment period', 'timeFrame': 'Day 56'}]}, 'conditionsModule': {'conditions': ['Elevated LDL Cholesterol']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged ≥18 and \\<75 years.\n* Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.\n* LDL-cholesterol ≥130 and ≤220 mg/dL.\n* Systolic blood pressure ≥120 and \\<160 mmHg and diastolic blood pressure ≥70 and \\<100 mmHg.\n* Provide written informed consent.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01362218', 'briefTitle': 'Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferrer Internacional S.A.'}, 'officialTitle': 'Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol', 'orgStudyIdInfo': {'id': 'P-100820-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed Dose Combination Pill', 'description': 'A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)', 'interventionNames': ['Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid', 'interventionNames': ['Drug: Simvastatin, ramipril, acetylsalicylic acid']}], 'interventions': [{'name': 'Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)', 'type': 'DRUG', 'description': 'A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.', 'armGroupLabels': ['Fixed Dose Combination Pill']}, {'name': 'Simvastatin, ramipril, acetylsalicylic acid', 'type': 'DRUG', 'description': 'A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks', 'armGroupLabels': ['Simvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferrer Internacional S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}