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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00701649
First received: June 18, 2008
Last updated: December 1, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Hypertension
Biological: CYT006-AngQb
Biological: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Adverse events: quality, quantity, severity [ Time Frame: Throughout the study until week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: CYT006-AngQb
s.c.
Placebo Comparator: 2 Biological: Placebo
s.c.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90-109 mmHg on 2 consecutive visits (screening and V1).
  • Daytime blood pressure above threshold for definition of hypertension in the screening ABPM measurement (SBP >135 mmHg).
  • Patients without current antihypertensive therapy.
  • Patients on antihypertensive therapy, which can be stopped.
  • 18 to 69 years of age.
  • Male patients, or female patients without childbearing potential .

Exclusion Criteria:

  • Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105-1187), i.e. those with:
  • grade III hypertension (mean sitting office SBP ≥180mmHg and/or mean sitting DBP≥110mmHg)
  • history or presence of established cardiovascular or renal disease:
  • Ischemic stroke, cerebral hemorrhage, transient ischemic attack
  • Myocardial infarction, angina pectoris, coronary re-vascularization, heart failure
  • Peripheral artery disease
  • Diabetic nephropathy
  • Known autoimmune disease.
  • Severe allergy.
  • Pregnancy or breastfeeding.
  • Women in childbearing age that are not surgically sterilized.
  • Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
  • Current diagnosis or history of malignancy.
  • Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
  • Drug or alcohol abuse within the past 2 years.
  • Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
  • Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
  • Previous participation in a clinical trial with a Qb based vaccine.
  • Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
  • Possible dependency of the patient on sponsor and/or investigator.
  • Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
  • Donation or loss >=400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701649

Locations
Germany
CRS Mannheim
Mannheim, Germany, D-68167
CRS Mönchengladbach
Mönchengladbach, Germany, D-41061
Switzerland
University Hospital Basel
Basel, Switzerland, CH-4031
Inselspital
Bern, Switzerland, CH-3010
Hopital Universitaire Geneve
Geneva, Switzerland, CH-1211
Med Zentrum Römerhof
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
Cytos Biotechnology AG
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Jürg Nussberger, Hôpital Nestlé 6027, CHUV, CH-1011 Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT00701649     History of Changes
Other Study ID Numbers: CYT006-AngQb 02, Eudract No. 2007-005843-93
Study First Received: June 18, 2008
Last Updated: December 1, 2009
Health Authority: Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut

Keywords provided by Cytos Biotechnology AG:
mild essential hypertension
moderate essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014