NCT00701649

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Mar 2008

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

June 18, 2008

Last Update Submit

December 1, 2009

Conditions

Hypertension

Keywords

mild essential hypertensionmoderate essential hypertension

Outcome Measures

Primary Outcomes (1)

  • Adverse events: quality, quantity, severity

    Throughout the study until week 48

Secondary Outcomes (3)

  • Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline

    24 hours

  • Titer of IgG specific for angiotensin II

    Throughout the study untill week 48

  • Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone)

    24 hours

Study Arms (2)

1

EXPERIMENTAL
Biological: CYT006-AngQb

2

PLACEBO COMPARATOR
Biological: Placebo

Interventions

CYT006-AngQbBIOLOGICAL

s.c.

1
PlaceboBIOLOGICAL

s.c.

2

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • to 69 years of age.
  • Male patients, or female patients without childbearing potential .

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CRS Mannheim

Mannheim, D-68167, Germany

Location

CRS Mönchengladbach

Mönchengladbach, D-41061, Germany

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Inselspital

Bern, CH-3010, Switzerland

Location

Hopital Universitaire Geneve

Geneva, CH-1211, Switzerland

Location

Med Zentrum Römerhof

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

CYT006-AngQb

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

DE(2)CH(4)