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Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00710372
First received: July 3, 2008
Last updated: November 11, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Mild Essential Hypertension
Moderate Essential Hypertension
 Biological: CYT006-AngQb
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Adverse events: quality, quantity, severity [ Time Frame: throughout complete study until week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in daytime, nighttime and 24h ambulatory blood pressure from baseline [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • anti-Angio II IgG antibody titer [ Time Frame: throughout complete study until week 48 ] [ Designated as safety issue: No ]
  • Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone) [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CYT006-AngQb
 Biological: CYT006-AngQb
s.c. injection
Placebo Comparator: 2 Biological: CYT006-AngQb
s.c. injection

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710372

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

No publications provided

Responsible Party: Cytos Biotechnology, Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00710372     History of Changes
Other Study ID Numbers: CYT006-AngQb 03, EudraCT No.: 2007-007516-28
Study First Received: July 3, 2008
Last Updated: November 11, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013