ID
25144
Beskrivning
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Eligibility Question
Nyckelord
Versioner (4)
- 2017-08-27 2017-08-27 -
- 2017-10-13 2017-10-13 -
- 2017-10-23 2017-10-23 -
- 2017-12-12 2017-12-12 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903
Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903
Beskrivning
Inclusion Criteria
Beskrivning
Subject must understand the aims, investigational procedures and possible consequences of the study).
Datatyp
boolean
Beskrivning
Refer to Appendix 1: Highly Effective Methods For Avoidance Of Pregnancy In Women Of Childbearing Potential. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
Datatyp
boolean
Beskrivning
statin therapy
Datatyp
boolean
Beskrivning
Chronic CHD documented by at least one of the following: a. prior MI (>1 month prior to randomisation). b. prior coronary revascularization procedure [percutaneous coronary intervention (PCI) > 1 month prior to randomization or coronary artery bypass graft (CABG) >3 months prior to randomization]. c. multivessel CHD involving major epicardial coronary arteries confirmed by coronary angiography at any time (without revascularization).
Datatyp
boolean
Beskrivning
At least one of the following additional predictors of CV risk [a through f]: a. age >60 years at randomization. b. diabetes mellitus requiring pharmacothearpy. c. HDL-C <40 mg/dL (1.03 mmol/L). d. smoker (defined as at least 5 cigarettes per day on average) or a previous smoker (defined as at least 5 cigarettes per day on average when smoking) who discontinued within the past 3 months. e. significant renal dysfunction (defined as estimated glomerular filtration rate [eGFR] >30 and <59 mL/min per 1.73 m2 OR urine ACR >30 mg albumin/g creatinine). f. polyvascular disease manifested as coexistent clinically diagnosed arterial disease in at least 2 arterial territories, defined as: > chronic CHD and cerebrovascular disease defined as carotid artery disease or prior ischemic stroke >3 months. OR > chronic CHD and peripheral arterial disease (PAD).
Datatyp
boolean
Beskrivning
Exclusion Criteria
Beskrivning
Planned coronary revascularization
Datatyp
boolean
Beskrivning
Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence of abnormal liver function test [total bilirubin or alkaline phosphatase >1.5 x upper limit of normal (ULN); or ALT or AST >2.5 x ULN] or other hepatic abnormalities that in the opinion of the Investigator would preclude the subject from participation in the study.
Datatyp
boolean
Beskrivning
renal impairment
Datatyp
boolean
Beskrivning
heart failure
Datatyp
boolean
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hypertension
Datatyp
boolean
Beskrivning
(e.g., very severe chronic airways disease, known human immunodeficiency virus [HIV] positive, or cancer in the past five years other than non-melanoma skin cancer).
Datatyp
boolean
Beskrivning
asthma
Datatyp
boolean
Beskrivning
All female subjects of childbearing potential must have a urine ß?-human chorionic gonadotropin [hCG] pregnancy test performed at Screening and/or within 7 days prior to randomization.
Datatyp
boolean
Beskrivning
Refer to Appendix 2: Clinical criteria for diagnosing anaphylaxis [Sampson, 2006]
Datatyp
boolean
Beskrivning
Alcohol or drug abuse
Datatyp
boolean
Beskrivning
intake CYP3A4 inhibitors
Datatyp
boolean
Beskrivning
Lp-PLA2 activity
Datatyp
boolean
Beskrivning
exposure to darapladib
Datatyp
boolean
Beskrivning
Use of another investigational product
Datatyp
boolean
Beskrivning
study of investigational device
Datatyp
boolean
Beskrivning
other reason for exclusion
Datatyp
boolean