Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

NCT ID: NCT00710372

Last Updated: 2010-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

CYT006-AngQb

Group Type: EXPERIMENTAL

CYT006-AngQb

Intervention Type: BIOLOGICAL

s.c. injection

2

Group Type: PLACEBO_COMPARATOR

CYT006-AngQb

Intervention Type: BIOLOGICAL

s.c. injection

Interventions

CYT006-AngQb

s.c. injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytos Biotechnology AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Cytos Biotechnology AG

Locations

Cytos Biotechnology (Sponsor's Headquarter)

Schlieren, , Switzerland

Countries

Switzerland

Other Identifiers

EudraCT No.: 2007-007516-28

Identifier Type: -

Identifier Source: secondary_id

CYT006-AngQb 03

Identifier Type: -

Identifier Source: org_study_id