ID
26243
Description
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
Keywords
Versions (4)
- 8/27/17 8/27/17 -
- 10/13/17 10/13/17 -
- 10/23/17 10/23/17 -
- 12/12/17 12/12/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 13, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903
Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903
Description
Inclusion Criteria
Description
Subject must understand the aims, investigational procedures and possible consequences of the study).
Data type
boolean
Description
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.
Data type
boolean
Description
statin therapy
Data type
boolean
Description
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).
Data type
boolean
Description
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).
Data type
boolean
Description
Exclusion Criteria
Description
Planned coronary revascularization
Data type
boolean
Description
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.
Data type
boolean
Description
renal impairment
Data type
boolean
Description
heart failure
Data type
boolean
Description
hypertension
Data type
boolean
Description
(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).
Data type
boolean
Description
asthma
Data type
boolean
Description
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.
Data type
boolean
Description
Refer to Appendix 2: Clinical criteria for diagnosing anaphylaxis [Sampson, 2006]
Data type
boolean
Description
Alcohol or drug abuse
Data type
boolean
Description
intake CYP3A4 inhibitors
Data type
boolean
Description
Lp-PLA2 activity
Data type
boolean
Description
exposure to darapladib
Data type
boolean
Description
Use of another investigational product
Data type
boolean
Description
study of investigational device
Data type
boolean
Description
other reason for exclusion
Data type
boolean