Mild Essential Hypertension, Moderate Essential Hypertension
Conditions
Brief summary
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.
Interventions
BIOLOGICALCYT006-AngQb
s.c. injection
Sponsors
Cytos Biotechnology AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events: quality, quantity, severity | throughout complete study until week 48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed