Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension
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|ClinicalTrials.gov Identifier: NCT00701649|
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : December 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Biological: CYT006-AngQb Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||November 2009|
|Placebo Comparator: 2||
- Adverse events: quality, quantity, severity [ Time Frame: Throughout the study until week 48 ]
- Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline [ Time Frame: 24 hours ]
- Titer of IgG specific for angiotensin II [ Time Frame: Throughout the study untill week 48 ]
- Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone) [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|