Hyperbilirubinemia, the favourable side effect of atazanavir? Influence of atazanavir treatment on endothelial dysfunction, vascular inflammation and heme oxygenase activity in type 2 diabetes mellitus. - Hyperbilirubinemia, the favourable side effect of atazanavir?

RUNMC0 个研究点开始时间: 2008年2月28日最近更新: 2012年3月19日

适应症

试验速览

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•- At least 18 and not older than 65 years of age on the day of the first dosing.
•- Type 2 diabetes mellitus treated with diet, oral medication and/or insulin.
•- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
•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) no
•F.1.3.1 Number of subjects for this age range

•- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
•- History of smoking within the past year
•- History of or current abuse of drugs, alcohol or solvents.
•- Current use of antihypertensive, cardiac or other vasoactive medication.
•- Current use of acetylsalicylic acid
•- Use of antioxidant vitamin supplements
•- Use of acid suppressive medication
•- Inability to suspend the use of statins during trial participation
•- Clinical evidence of cardiac or pulmonary disease
•- Laboratory evidence of renal or hepatic abnormalities, defined as results exceeding twice the upper limit of normal range.
•- Cardiac conduction abnormalities, consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
•- Subjects with Gilbert Syndrome, which is suggested by an unconjucated hyperbilirubinemia (total bilirubin level above 10 µmol/L and a normal direct bilirubin level) and has to be confirmed by genetic testing.

发起方

RUNMC