Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

Mild Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710372
• Other study ID #: CYT006-AngQb 03
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2008
• Last updated: November 11, 2010
• Start date: June 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Mild Essential Hypertension
• Moderate Essential Hypertension

Intervention

Biological:
• CYT006-AngQb
s.c. injection

Locations

Country	Name	City	State
Switzerland	Cytos Biotechnology (Sponsor's Headquarter)	Schlieren

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events: quality, quantity, severity		throughout complete study until week 48	Yes
Secondary	Change in daytime, nighttime and 24h ambulatory blood pressure from baseline		24 hours	No
Secondary	anti-Angio II IgG antibody titer		throughout complete study until week 48	No
Secondary	Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)		24 h	No