Clinical trial NCT00710372: Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Essential Hypertension
Moderate Essential Hypertension
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events: quality, quantity, severity
timeFrame: throughout complete study until week 48
Secondary outcomes:
measure: Change in daytime, nighttime and 24h ambulatory blood pressure from baseline
timeFrame: 24 hours
measure: anti-Angio II IgG antibody titer
timeFrame: throughout complete study until week 48
measure: Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)
timeFrame: 24 h
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Cytos Biotechnology (Sponsor's Headquarter)
Study officials:
References: