NCT00701649

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cytos Biotechnology AG · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BIOLOGICAL	CYT006-AngQb	s.c.
BIOLOGICAL	Placebo	s.c.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-11-01
• First posted: 2008-06-19
• Last updated: 2009-12-02

Locations

6 sites across 2 countries: Germany, Switzerland