Effects of tetrahydrobiopterin (6R-BH4) on flow-mediated dilation in CADASIL patients: a randomised controlled trial - CADASIL BH4

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2007年12月11日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Age > 30 and ≤ 65 years
•- Diagnosis of CADASIL confirmed by the identification of a mutation in the Notch3 gene
•- Informed consent
•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

•-Dementia (DSM-IV criteria) with a SIDAM score <33
•-Autoimmune disorders
•-Pregnancy, nursing or childbearing potential not on adequate contraception
•-Myocardial infarction, cerebral vascular accident, or pulmonary embolism during the 3 months prior to Screening.
•-Severe uncontrolled hypertension (BP >180 mmHg systolic and /or 110 mmHg diastolic).
•-Hypotension at Screening, defined as seated resting BP values of < 100 mmHg systolic or < 55 mmHg diastolic, or as symptomatic (orthostatic) hypotension
•-Serum creatinine >2.5 mg/dL or hepatic enzymes >2X normal
•-Pacemakers, implantable cardioverter defibrillators or metallic implants not compatible with MRI scanning
•-Concomitant treatment with methotrexate, levodopa, phosphodiesterase-3 (milrinone) or phosphodiesterase -5 inhibitors (sildenafil, taladafil, vardenafil) , pentoxyfylline, nitrate/nitrite-based vasodilators, L-arginine, or dietary supplements containing L-arginine or gingko biloba within 30 days prior to Screening, or anticipated need for treatment with any of these agents during the course of the study.
•-Participation in other drug trials within the last 30 days before start for the study

发起方

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)