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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014