Completed

NCT Number: NCT00710372

Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Essential Hypertension Moderate Essential Hypertension

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cytos Biotechnology (Sponsor's Headquarter)

Schlieren, CH-8952, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CYT006-AngQb

Biological

s.c. injection

Primary outcomes

Adverse events: quality, quantity, severity

Time frame: throughout complete study until week 48

Secondary outcomes

Change in daytime, nighttime and 24h ambulatory blood pressure from baseline

Time frame: 24 hours
anti-Angio II IgG antibody titer

Time frame: throughout complete study until week 48
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)

Time frame: 24 h

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Jul 4, 2008
Registry last updated: Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.