Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT00291902
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2006-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Italy', 'Luxembourg', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574213', 'term': 'dilmapimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CHD', 'coronary heart disease', 'atherosclerosis', 'inflammation'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '20689074', 'type': 'DERIVED', 'citation': 'Sarov-Blat L, Morgan JM, Fernandez P, James R, Fang Z, Hurle MR, Baidoo C, Willette RN, Lepore JJ, Jensen SE, Sprecher DL. Inhibition of p38 mitogen-activated protein kinase reduces inflammation after coronary vascular injury in humans. Arterioscler Thromb Vasc Biol. 2010 Nov;30(11):2256-63. doi: 10.1161/ATVBAHA.110.209205. Epub 2010 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females must be of non-child-bearing potential.\n* Female subjects must have a negative pregnancy test.\n* Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.\n* Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL \\<130 mg/dL (3.4 mmol/L) at Screening visit.\n* Must be capable of providing informed consent.\n* Have an hsCRP concentration of \\>2 mg/L, but \\< 10 mg/L at screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding.\n* Planned PCI with multi-vessel stenting.\n* Planned PCI with additional revascularization procedures staged at different days during the study period.\n* Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).\n* Planned PCI of any bypass graft.\n* History of CABG surgery.\n* Planned cardiac or major non-cardiac surgery within the study period.\n* Disabling stroke in the past 6 months.\n* History of chronic viral hepatitis or other chronic hepatic disorders.\n* History of Gilbert's syndrome or elevated bilirubin concentrations at screening.\n* History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.\n* Renal impairment with serum creatinine \\>2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.\n* Current inadequately controlled hypertension (blood pressure \\>160 mmHg systolic and/or \\>100 mmHg diastolic) on a stable dose of antihypertensive medication.\n* Current poorly controlled diabetes mellitus, defined as HbA1c \\>10% at Screening.\n* History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF\\<30%) regardless of symptomatic status.\n* History of malignancy within the past 5 years, other than non-melanoma skin cancer.\n* Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.\n* Alcohol or drug abuse within the past 6 months."}, 'identificationModule': {'nctId': 'NCT00291902', 'briefTitle': 'A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 28-day, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 (7.5 mg) in Subjects With Coronary Heart Disease (CHD) Undergoing Elective Percutaneous Coronary Interventions (PCI)', 'orgStudyIdInfo': {'id': 'PMK103351'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB-681323', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '6100', 'city': 'Haderslev', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.24943, 'lon': 9.48771}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '60-355', 'city': 'Poznan', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}