Essential Hypertension Clinical Trial
This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in
healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine
CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm,
but open with respect to AngQb dose escalation.
In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen
consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety
and tolerability profile, as judged by the independent safety monitoring board, arm two is
enrolled.
In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of
100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections
are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and
tolerability profile, as judged by the independent safety monitoring board, arm three is
enrolled.
In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of
300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections
are given 4 and 12 weeks after the first injection, respectively.
The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens
of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential
hypertension. Secondary objectives include the assessment of pharmacodynamic effects and
their dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the
exploration of clinical efficacy (effects on systolic and diastolic blood pressure)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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