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Sponsored by: |
Cytos Biotechnology AG |
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Information provided by: | Cytos Biotechnology AG |
ClinicalTrials.gov Identifier: | NCT00701649 |
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:
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Biological: CYT006-AngQb Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: CYT006-AngQb
s.c.
|
2: Placebo Comparator |
Biological: Placebo
s.c.
|
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
CRS Mannheim | |
Mannheim, Germany, D-68167 | |
CRS Mönchengladbach | |
Mönchengladbach, Germany, D-41061 | |
Switzerland | |
University Hospital Basel | |
Basel, Switzerland, CH-4031 | |
Med Zentrum Römerhof | |
Zürich, Switzerland, CH-8091 | |
Hopital Universitaire Geneve | |
Geneva, Switzerland, CH-1211 | |
Inselspital | |
Bern, Switzerland, CH-3010 |
Responsible Party: | Hôpital Nestlé 6027, CHUV, CH-1011 Lausanne, Switzerland ( Prof. Dr. med. Jürg Nussberger ) |
Study ID Numbers: | CYT006-AngQb 02, Eudract No. 2007-005843-93 |
Study First Received: | June 18, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00701649 |
Health Authority: | Switzerland: Swissmedic; Germany: Paul-Ehrlich-Institut |
mild essential hypertension moderate essential hypertension |
Vascular Diseases Essential hypertension Angiotensin II Hypertension |
Cardiovascular Diseases |