Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Adverse events: quality, quantity, severity [ Time Frame: Throughout the study until week 48 ] [ Designated as safety issue: Yes ]
- Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Titer of IgG specific for angiotensin II [ Time Frame: Throughout the study untill week 48 ] [ Designated as safety issue: No ]
- Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 2||
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701649
|Mannheim, Germany, D-68167|
|Mönchengladbach, Germany, D-41061|
|University Hospital Basel|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Hopital Universitaire Geneve|
|Geneva, Switzerland, CH-1211|
|Med Zentrum Römerhof|
|Zürich, Switzerland, CH-8091|