Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

NCT00710372 | Completed Phase 2

• 2 other identifiers: CYT006-AngQb 03EudraCT No.: 2007-007516-28
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Essential Hypertension; Moderate Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Adverse events: quality, quantity, severity

  throughout complete study until week 48

Secondary Outcomes (3)

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

  24 hours

• anti-Angio II IgG antibody titer

  throughout complete study until week 48

• Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)

  24 h

Study Arms (2)

1

EXPERIMENTAL

CYT006-AngQb

Biological: CYT006-AngQb

2

PLACEBO COMPARATOR

Biological: CYT006-AngQb

Interventions

CYT006-AngQb BIOLOGICAL

s.c. injection

1; 2

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• mmHg 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.

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

Study Sites (1)

Cytos Biotechnology (Sponsor's Headquarter)

Schlieren, CH-8952, Switzerland

Location

MeSH Terms

Interventions

CYT006-AngQb

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 4, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2010
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

CH (1)