drugset / Trial / NCT00701649

Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension

NCT00701649 ↗

Phase 2 Completed 60 enrolled Cytos Biotechnology AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is administered by subcutaneous injection. The objectives of the study are: * To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II). * To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers. * To explore the effect on blood pressure using ABPM.

Timeline

Start
2008-03
Primary completion
2009-03
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CYT006-AngQb Vaccine 300 ug Subcutaneous