Clincosm LogoSign in Get a demo

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

Sponsor
Cytos Biotechnology AG (Industry)
Overall Status
Completed
CT.gov ID
NCT00701649
Collaborator
(none)
60
Enrollment
6
Locations
2
Arms
20
Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CYT006-AngQb
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Biological: CYT006-AngQb
s.c.
Placebo Comparator: 2

Biological: Placebo
s.c.

Outcome Measures

Primary Outcome Measures

  1. Adverse events: quality, quantity, severity [Throughout the study until week 48]

Secondary Outcome Measures

  1. Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline [24 hours]

  2. Titer of IgG specific for angiotensin II [Throughout the study untill week 48]

  3. Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone) [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CRS Mannheim Mannheim Germany D-68167
2 CRS Mönchengladbach Mönchengladbach Germany D-41061
3 University Hospital Basel Basel Switzerland CH-4031
4 Inselspital Bern Switzerland CH-3010
5 Hopital Universitaire Geneve Geneva Switzerland CH-1211
6 Med Zentrum Römerhof Zürich Switzerland CH-8091

Sponsors and Collaborators

  • Cytos Biotechnology AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00701649
Other Study ID Numbers:
  • CYT006-AngQb 02
  • Eudract No. 2007-005843-93
First Posted:
Jun 19, 2008
Last Update Posted:
Dec 2, 2009
Last Verified:
Dec 1, 2009
Keywords provided by , ,
mild essential hypertension
moderate essential hypertension
Additional relevant MeSH terms:
Hypertension
Essential Hypertension

Study Results

No Results Posted as of Dec 2, 2009