Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710372
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : November 15, 2010
Information provided by:
Cytos Biotechnology AG

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.

Condition or disease Intervention/treatment Phase
Mild Essential Hypertension Moderate Essential Hypertension Biological: CYT006-AngQb Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1
Biological: CYT006-AngQb
s.c. injection

Placebo Comparator: 2 Biological: CYT006-AngQb
s.c. injection

Primary Outcome Measures :
  1. Adverse events: quality, quantity, severity [ Time Frame: throughout complete study until week 48 ]

Secondary Outcome Measures :
  1. Change in daytime, nighttime and 24h ambulatory blood pressure from baseline [ Time Frame: 24 hours ]
  2. anti-Angio II IgG antibody titer [ Time Frame: throughout complete study until week 48 ]
  3. Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone) [ Time Frame: 24 h ]

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710372

Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, Switzerland, CH-8952
Sponsors and Collaborators
Cytos Biotechnology AG

Responsible Party: Cytos Biotechnology, Cytos Biotechnology AG Identifier: NCT00710372     History of Changes
Other Study ID Numbers: CYT006-AngQb 03
EudraCT No.: 2007-007516-28
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases