NCT00802893终止2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel Study of Oral 6R-BH4 in Subjects With Isolated Systolic Hypertension and Endothelial Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function
研究概览
简要总结
This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.
详细描述
By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No change in prescribed antihypertension medications within the previous 30 days
- •Study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for FMD measurements
- •ISH with the following mean seated BP: SBP > 145 and < 180 mmHg. Diastolic blood pressure < 90mmHg
排除标准
- •Has known hypersensitivity to 6RBH4 or its excipients
- •Pregnant or breastfeeding at screening
- •Use of any investigational product or investigational medical device within 30 days prior to screening
- •Current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
- •Hypertension secondary to other medical conditions
- •Any severe comorbid condition that would limit life expectancy to <6 months
- •Current use of any nicotine containing substances
- •History of drug or alcohol abuse
- •MI, stroke or surgery within 90 days before Screening Visit
- •CABG within 6 months before the Screening Visit
- •Serum creatinine >2.0mg/dl or AST, ALT, GGT levels >2times upper limit of normal
- •Concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
- •Previous treatment with any formulation of BH4
研究组 & 干预措施
Experimental Drug
Experimental
干预措施: 6R-BH4 (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function
时间窗: 4-6 weeks
次要结局
- Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness(4-8 weeks)
研究者
研究点 (1)
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