NCT00710372CompletedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Adverse events: quality, quantity, severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2
Placebo Comparator
Intervention: CYT006-AngQb (Biological)
1
Experimental
CYT006-AngQb
Intervention: CYT006-AngQb (Biological)
Outcomes
Primary Outcomes
Adverse events: quality, quantity, severity
Time Frame: throughout complete study until week 48
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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