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Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

Primary Purpose

Mild Essential Hypertension, Moderate Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
CYT006-AngQb
Sponsored by
Cytos Biotechnology AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Essential Hypertension

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cytos Biotechnology (Sponsor's Headquarter)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

CYT006-AngQb

Outcomes

Primary Outcome Measures

Adverse events: quality, quantity, severity

Secondary Outcome Measures

Change in daytime, nighttime and 24h ambulatory blood pressure from baseline
anti-Angio II IgG antibody titer
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)

Full Information

First Posted
July 3, 2008
Last Updated
November 11, 2010
Sponsor
Cytos Biotechnology AG
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1. Study Identification

Unique Protocol Identification Number
NCT00710372
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytos Biotechnology AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Essential Hypertension, Moderate Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CYT006-AngQb
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CYT006-AngQb
Intervention Description
s.c. injection
Primary Outcome Measure Information:
Title
Adverse events: quality, quantity, severity
Time Frame
throughout complete study until week 48
Secondary Outcome Measure Information:
Title
Change in daytime, nighttime and 24h ambulatory blood pressure from baseline
Time Frame
24 hours
Title
anti-Angio II IgG antibody titer
Time Frame
throughout complete study until week 48
Title
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)
Time Frame
24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cytos Biotechnology (Sponsor's Headquarter)
City
Schlieren
ZIP/Postal Code
CH-8952
Country
Switzerland

12. IPD Sharing Statement

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Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

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