Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT00139061
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2005-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C483909', 'term': 'torcetrapib'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2006-05'}, 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.'}], 'secondaryOutcomes': [{'measure': 'Changes in levels of lipid parameters and other biomarkers'}]}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'The Torcetrapib project was terminated on December 2, 2006 due to safety findings.\n\nTo assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.', 'detailedDescription': 'For additional information please call: 1-800-718-1021'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Fredrickson Type IIB dyslipidema (Mixed Hyperlipidemia)\n* Men and women at least 18 years of age\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating, or planning to become pregnant.\n* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid\n* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors\n* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study'}, 'identificationModule': {'nctId': 'NCT00139061', 'briefTitle': 'Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia', 'orgStudyIdInfo': {'id': 'A5091034'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Torcetrapib/Atorvastatin', 'type': 'DRUG'}, {'name': 'Fenofibrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49 000', 'city': 'Angers', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49 100', 'city': 'Angers', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33 200', 'city': 'Bordeaux Cauderan', 'country': 'France', 'facility': 'Pfizer Investigational Site'}, {'zip': '49125', 'city': 'Briollay', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.56446, 'lon': -0.50805}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '57 300', 'city': 'Hagondange', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24879, 'lon': 6.16374}}, {'zip': '40 280', 'city': 'Haut-Mauco', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.82632, 'lon': -0.55491}}, {'zip': '54800', 'city': 'Jarny', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.15873, 'lon': 5.8764}}, {'zip': '59 037 Cedex', 'city': 'Lille', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '54800', 'city': 'Mars-la-Tour', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.09882, 'lon': 5.88578}}, {'zip': '57070', 'city': 'Metz', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '32 240', 'city': 'Monguilhem', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.85513, 'lon': -0.18166}}, {'zip': '40 010 cedex', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '40 010', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '40000', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '40010', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '54660', 'city': 'Moûtiers', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.48459, 'lon': 6.53146}}, {'zip': '49610', 'city': 'Mûrs-Erigné', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.39592, 'lon': -0.55293}}, {'zip': '44 093 Cedex 01', 'city': 'Nantes', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '21 850', 'city': 'Pouilly-en-Auxois', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.26238, 'lon': 4.55583}}, {'zip': '40 240', 'city': 'Saint-Justin', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.98022, 'lon': -0.23204}}, {'zip': '40090', 'city': "Saint-Martin-d'Oney", 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.92757, 'lon': -0.64133}}, {'zip': '31600', 'city': 'Seysses', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '79100', 'city': 'Thouars', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.9815, 'lon': -0.21175}}, {'zip': '49 125', 'city': 'Tiercé', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.6157, 'lon': -0.46787}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}