A Double Blind, Randomized, Placebo Controlled, Parallel Group Phase IIa Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients with Mild to Moderate Essential Hypertension.

Conditions: Mild to moderate essential hypertension
MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

Registration Number: EUCTR2007-005843-93-DE

Lead Sponsor: Cytos Biotechnology AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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 screening ABPM measurement (SBP >130 mmHg and/or DBP >85 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. For patients on previous antihypertensive therapy, who can safely stop their medication, the screening period will be prolonged for a wash-out phase, not shorter than 2 weeks. The screening” office blood pressure and ABPM should be assessed at the end of the wash-out period to confirm the inclusion criteria.
• 18 to 69 years of age.
• Male patients, or female patients without childbearing potential (postmenopausal - one year without menses, in case of doubts serum FSH should be determined and must be >30 U/mL) or surgically sterilized, documented).
• Written informed consent must be signed before any study related procedure is performed including start of a wash-out from previous antihypertensive treatment.
• Patient is willing and able to comply with all trial requirements and procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with very high added risk” according to ESH/ESC 2007 Guidelines for the Management of Arterial Hypertension, i.e. those with:
- grade III hypertension (mean sitting office SBP =180mmHg and/or mean sitting 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, heart failure
- Clinically relevant left ventricular dysfunction (NYHA class II-IV)
- Peripheral artery disease
- Diabetic nephropathy
• Electrocardiographic confirmed left ventricular hypertrophy (Sokolow-Lyon=sum of
SV1+RV5 or V6>38 mm [3.8mV]
• Increased plasma creatinin (M >115µmol/l, W >107 µmol/l).
• Albumin/creatinine ratio in spot urine (M ? 22mg/g, W ? 31mg/g).
• Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.
• Fasting plasma glucose > 5.9 mmol/l
• Body mass index (BMI) > 32
• LDL cholesterol > 4.9 mmol/l
• Triglycerides > 3.4 mmol/l
• Postural hypotension at screening (fall of SBP from sitting to standing position >20 mmHg or DBP >10 mmHg) or clinical signs of orthostatic hypotension.
• Patient requiring long-term usage of not allowed concomitant medication. For details, please refer to Section Concomitant medication”.
• 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.
• Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
• Drug or alcohol abuse within the past 2 years.
• Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
• Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
• Previous participation in a clinical trial with a Qb based vaccine (CYT006-AngQb, CYT001-DerQb, CYT002-NicQb, CYT003-QbG10, CYT005-AllQbG10, CYT007-TNFQb and CYT009-GhrQb).
• Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
• Possible dependency of the patient on sponsor and/or investigator.
• Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
• Donation or loss =400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.