A multi-centre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10 mg daily doses of GW501516 in subjects with low HDLc

GlaxoSmithKine Research & Development Limited0 sites424 target enrollmentJune 29, 2004

Overview

No summary available.

Registry

who.int

Start Date

June 29, 2004

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKine Research & Development Limited

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\. Male or female subjects aged 18 to 75 years.
•2\. Females must be of non\-childbearing potential (surgically sterile or post\-menopausal \[amenorrhoeic] for more than one year).
•3\. Fasting plasma HDLc concentration less than or equal to 45mg/dL (less than or equal to 1\.16mmol/L)
•4\. Subjects whose plasma LDLc concentration does not require treatment according to the NCEP/ATPIII guidelines:
•? Plasma LDLc concentration less than or equal to 190mg/dL (less than or equal to 4\.91mmol/L) if no more than one cardiovascular risk factor, or
•? Plasma LDLc concentration less than or equal to 160mg/dL (less than or equal to 4\.13mmol/L) if two or more cardiovascular risk factors, and a 10\-year CHD risk less than or equal to 10% (Framingham Point Scores; see Section 14\.8\), or
•? Plasma LDLc concentration less than or equal to 130mg/dL (less than or equal to 3\.36mmol/L) if two or more cardiovascular risk factors, and a 10\-year CHD risk \>10% and less than or equal to 20% (Framingham Point Scores).
•5\. Fasting plasma TG concentration less than or equal to 500mg/dL (less than or equal to 5\.65mmol/L).
•Are the trial subjects under 18? no

•1\. A medical history significant for the following:
•? CHD, heart failure, stroke, peripheral vascular disease, angina pectoris or previous myocardial infarction) or a 10\-year risk for developing CHD \>20% (Framingham Point Scores).
•? QTc interval \>440msec (males) or \>450msec (females) at screening.
•? Known Type 1 or Type 2 diabetes mellitus or fasting plasma glucose (FPG) at screening AND at Visit 2 both \>126mg/dL (\>7mmol/L).
•? History of renal disease or renal impairment or serum creatinine \>1\.5mg/dL (135micromol/L) at screening.
•? History of metabolic acidosis or rhabdomyolysis, or a history of myalgia, myositis or myopathy after taking statins and/or fibrates, or CPK \>3 x ULN at screening.
•? Pre\-existing gallbladder disease (unless the subject has since undergone a cholescystectomy).
•? History of chronic pancreatitis.
•? History of familial adenomatous polyposis or colonic polyps.
•? History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders; or ALT or AST \>2 x ULN, or alkaline phosphatase or total bilirubin \>1\.5 x ULN of laboratory reference range at screening.