A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients with Dyslipidemia - A3309 in Dyslipidemia

Albireo AB0 个研究点开始时间: 2009年12月18日最近更新: 2012年3月19日

研究概览

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•Dyslipidemia as measured by Total cholesterol evaluation and evaluation of other lipid parameter
•Male or non-pregnant females aged 18 to 80 years inclusive, with body mass index (BMI) 18.5 to 35 inclusive;
•Loose stools not present more often than once a month;
•Female subjects of childbearing potential, must have a negative serum pregnancy test at the Screening Visit (Clinic Visit 1);
•The patient agrees to refrain from making any new, major life-style changes that may affect the metabolism (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last study visit
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
•History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
•Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of IMP
•Known cardiovascular disease or manifestation of atherosclerosis
•Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
•S-Cholesterol >8.5 mmol/L
•S-Triglycerides > 4 mmol/L
•Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
•Any clinically significant findings on a Screening physical examination or 12 lead ECG
•Known or suspected history of drug or alcohol abuse as judged by the investigator
•Positive screen for alcohol and/or drugs of abuse at screening

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