ID
26243
Beschrijving
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
Trefwoorden
Versies (4)
- 27-08-17 27-08-17 -
- 13-10-17 13-10-17 -
- 23-10-17 23-10-17 -
- 12-12-17 12-12-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
13 oktober 2017
DOI
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Licentie
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
Beschrijving
Inclusion Criteria
Beschrijving
Subject must understand the aims, investigational procedures and possible consequences of the study).
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
statin therapy
Datatype
boolean
Beschrijving
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).
Datatype
boolean
Beschrijving
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).
Datatype
boolean
Beschrijving
Exclusion Criteria
Beschrijving
Planned coronary revascularization
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
renal impairment
Datatype
boolean
Beschrijving
heart failure
Datatype
boolean
Beschrijving
hypertension
Datatype
boolean
Beschrijving
(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).
Datatype
boolean
Beschrijving
asthma
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Refer to Appendix 2: Clinical criteria for diagnosing anaphylaxis [Sampson, 2006]
Datatype
boolean
Beschrijving
Alcohol or drug abuse
Datatype
boolean
Beschrijving
intake CYP3A4 inhibitors
Datatype
boolean
Beschrijving
Lp-PLA2 activity
Datatype
boolean
Beschrijving
exposure to darapladib
Datatype
boolean
Beschrijving
Use of another investigational product
Datatype
boolean
Beschrijving
study of investigational device
Datatype
boolean
Beschrijving
other reason for exclusion
Datatype
boolean