NCT00710372已完成2 期
A Double Blind, Randomized, Placebo Controlled, Parallel Group, Dose-Titration Phase II Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Adverse events: quality, quantity, severity
研究概览
简要总结
The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This form of presenting Ang II to the immune system induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against angiotensin II may offer a valuable alternative to conventional drugs for the treatment of hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90 -109 mmHg on 2 consecutive visits (screening and V1).
- •Daytime blood pressure above threshold for definition of hypertension in the baseline ABPM measurement (SBP >135 mmHg).
- •Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes <20mmHg for sitting office SBP and <10mmHg for mean sitting office DPB).
- •Patients without current antihypertensive therapy. Patients on previous mono-antihypertensive therapy, who can safely stop their medication
- •Patient is willing and able to comply with all trial requirements and procedures.
排除标准
- •Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105- 1187), i.e. those with:grade III hypertension (mean sitting office SBP
- •180mmHg and/or meansitting DBP ≥110mmHg/history or presence of established cardiovascular or renal disease (Ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ Myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (NYHA class II-IV)/ Peripheral artery disease/ Diabetic nephropathy
- •Electrocardiographic confirmed left ventricular hypertrophy
- •Increased plasma creatinine
- •Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.
- •Postural hypotension at screening
- •Arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
- •Known autoimmune disease.
- •Severe allergy.
- •Pregnancy or breastfeeding.
- •Women in childbearing age that are not surgically sterilized.
- •Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
- •Current diagnosis or history of malignancy.
结局指标
主要结局
Adverse events: quality, quantity, severity
时间窗: throughout complete study until week 48
次要结局
- Change in daytime, nighttime and 24h ambulatory blood pressure from baseline(24 hours)
- anti-Angio II IgG antibody titer(throughout complete study until week 48)
- Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)(24 h)
研究者
研究点 (2)
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