Status:
COMPLETED
Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension
Lead Sponsor:
Cytos Biotechnology AG
Conditions:
Mild Essential Hypertension
Moderate Essential Hypertension
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
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 presenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00710372
Start Date
June 1 2008
End Date
November 1 2010
Last Update
November 15 2010
Active Locations (1)
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1
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, Switzerland, CH-8952