Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00695305
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-08-25', 'releaseDate': '2017-07-25'}, {'resetDate': '2017-10-13', 'releaseDate': '2017-09-14'}], 'estimatedResultsFirstSubmitDate': '2017-07-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592856', 'term': 'rilapladib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2011-03-17', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2008-06-09', 'dispFirstSubmitQcDate': '2011-03-17', 'studyFirstSubmitQcDate': '2008-06-09', 'dispFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes.', 'timeFrame': '12 weeks'}, {'measure': 'LP-PLA2 activity;', 'timeFrame': '12 weeks'}, {'measure': 'changes in mean standard values of 18 FDG uptake as assessed by PET and MRI imaging', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Estimation of PK parameters (such as: apparent volume of distribution, apparent clearance, etc.) of rilapladib and their associated variability, appropriate to the final model', 'timeFrame': '12 weeks'}, {'measure': 'Estimation of PK/PD parameters (such as: IC50, Eo) and their associated variability, appropriate to the final model', 'timeFrame': '12 weeks'}, {'measure': '24 hour ambulatory blood pressure monitoring', 'timeFrame': '12 weeks'}, {'measure': 'PAF levels in human plasma as feasible', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rilapladib,', 'Lp-PLA2,', 'atherosclerosis', 'SB-659032,', 'FDG-PET,'], 'conditions': ['Atherosclerosis']}, 'referencesModule': {'availIpds': [{'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'LP2105521', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.', 'detailedDescription': 'Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity, plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of giving written informed consent and able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.\n* Male or female, aged 50 to 80 years inclusive, at screening.\n* Females must be of non-childbearing potential\n* Body weight ≥ 50 kg and BMI within the range 19-35 kg/m2\n* Documented atherosclerotic vascular disease (e.g. prior MI, prior revascularization, peripheral arterial disease, carotid disease, or cerebrovascular disease) and clinically stable for at least 6 months\n* If diabetic, have well controlled diabetes, defined for the purpose of this study as HbA1c ≤8% or FPG ≤200 mg/dL\n* Evidence of plaque inflammation \\[carotid artery or ascending aorta plaque inflammation defined as a tissue to background ratio (TBR) ≥ 1.6\\]\n* On a stable dose of a statin for 3 months prior to screening with no evidence of statin intolerance\n\nExclusion Criteria:\n\n* Recent (i.e., \\<6 months from Screening Visit) CV event defined as ST-elevation MI or non-ST-elevation MI, confirmed by cardiac enzyme elevation and ECG changes, coronary revascularization (PCI or CABG), stroke of any etiology, resuscitated sudden death, prior carotid surgery or stenting procedure\n* Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.\n* Exposure to substantial radiation within the past 12 months\n* Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy), PCI or major non-cardiac surgery within the study period\n* Current inadequately controlled hypertension (blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic) on a stable dose of anti-hypertensive medication\n* Diabetics taking injectable insulin at screening\n* Serum triglycerides \\>400 mg/dL, LDLc \\>130 mg/dL\n* Recent (\\<1 month) or ongoing acute infection.\n* History of chronic inflammatory disease\n* Recently received (\\<1 month) or currently receiving oral or injectable corticosteroids, or regular use of nasal, inhaled or topical corticosteroids.\n* Subjects who will commence, or who are likely to commence regular treatment with oral, non-steroidal anti-inflammatory drugs (NSAIDs) from screening until study completion\n* Currently receiving oral or injectable potent CYP3A4 inhibitor(s)\n* History of chronic viral hepatitis or other chronic hepatic disorders; or ALT or AST \\>1.5 x ULN, or alkaline phosphatase or total bilirubin \\>1.5 x ULN of laboratory reference range at Screen\n* Renal impairment with serum creatinine \\>2.0 mg/dl or history of kidney transplant or status post nephrectomy.\n* History of myopathy or inflammatory muscle disease, or elevated total CPK at screening\n* History of severe heart failure defined as NYHA class III or IV or those with known severe left ventricular dysfunction (ejection fraction\\<30%) regardless of symptomatic status\n* History of adult asthma (or reactive airway disease) manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)\n* History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions or severe allergic responses\n* History of malignancy within the past 2 years.\n* A history of glaucoma or any other findings in the baseline eye exam\n* Current life-threatening condition other than vascular disease that may prevent a subject from completing the study\n* QTc interval ≥450msec at screening or ≥480 msec for subjects with bundle branch block\n* History of drug abuse within the past 6 months\n* Previous exposure to rilapladib.\n* Contraindication to MRI scanning\n* Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication\n* Any other subject the Investigator deems unsuitable for the study'}, 'identificationModule': {'nctId': 'NCT00695305', 'briefTitle': 'An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multicenter, Randomized, 12 Week, Double-blind, Placebo-controlled, Parallel-group, Phase IIa Study Using 18F Fluorodeoxyglucose (FDG)-PET to Measure the Effects of Rilapladib on Macrophage Activity in Subjects With Atherosclerosis', 'orgStudyIdInfo': {'id': 'LP2105521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo to match', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rilapladib', 'description': '250 mg/day', 'interventionNames': ['Drug: rilapladib', 'Other: 18F Fluorodeoxylucose (FDG)-PET']}], 'interventions': [{'name': 'rilapladib', 'type': 'DRUG', 'otherNames': ['SB-659032'], 'description': '250 mg oral dose once daily', 'armGroupLabels': ['rilapladib']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}, {'name': '18F Fluorodeoxylucose (FDG)-PET', 'type': 'OTHER', 'otherNames': ['FDG marker'], 'description': 'FDG-PET', 'armGroupLabels': ['rilapladib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '01830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '07036', 'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10035', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11758', 'city': 'North Massapequa', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.70093, 'lon': -73.46207}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-07-25', 'type': 'RELEASE'}, {'date': '2017-08-25', 'type': 'RESET'}, {'date': '2017-09-14', 'type': 'RELEASE'}, {'date': '2017-10-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'GlaxoSmithKline'}}}}