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Created with Fabric.js 1.4.5 ITEM NO. 004 Phase III Clinical Trial: R-Itrol and Hyperlipidemia PHARM100 Assignment #1January 25, 2015Group Members: Keian Amina, Nolan Broeke, Sangeun Park,Fraser Stephenson, Adam Bernicky & Emma Roszak description here lorem ipsum dolor sit amet,consectetur adipsicsing elit Quality of Life (QOL) MeasureThe COOP/WONCA chart will be used because it has shown to accurately measure QOL in previous hyperlipidemia studies1. ComplianceAsk patient to relinquish all unused pills at final assessment.2 Count unused pills. Discard data from any participants that doesnt meet at least 60% compliance.2Compliant data (>85%) used as principal source of results with partially compliant data (84%-60%)as support.2 MethodsThis is a double-blind, randomized control trial. There will be 200 participants who meet the inclusion criteria. The study will compare R-Itrol to the gold standard statin, Atorvastatin (Lipitor).4 The subjects in the experimental group will take one R-Itrol pill each day after breakfast, for six weeks.4 Blood lipid levels will be assessed at baseline, after three weeks and again at the end of the six weeks.4 The placebo group will follow the same protocol as the experimental group.4 Basic InformationHyperlipidmemia is characterized by having high levels of lipids in the blood.4 Statins are the gold standard that are currently used to regulate this condition.4 Drug R-Itrol is a new drug that has a structure similar to omega-3 fatty acids. It functions to lower LDL cholesterol. Target PopulationCanadian adults, aged 18-79, with a diagnoses of hyperlipidemia. Inclusion CriteriaDiagnosis of low (LDL-C 100mg/dL), moderate ( 130mg/dL) or high ( 160mg/dL)hyperlipidemia Exclusion Criteria-Currently participating in another pharmacological trial4-Diagnoses of Type 1Diabetes or uncontrolled Type 2 Diabetes4-Unable to provide informed consent4 Outcome VariableThe outcome variable is LDL cholestrol.
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