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Safety, Tolerability, Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb

Sponsor
Cytos Biotechnology AG (Industry)
Overall Status
Completed
CT.gov ID
NCT00500786
Collaborator
(none)
88
Enrollment
5
Arms
28.9
Duration (Months)

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but open with respect to AngQb dose escalation.

In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm two is enrolled.

In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of 100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm three is enrolled.

In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of 300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively.

The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension. Secondary objectives include the assessment of pharmacodynamic effects and their dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the exploration of clinical efficacy (effects on systolic and diastolic blood pressure)

Condition or Disease Intervention/Treatment Phase
  • Biological: CYT006-AngQb
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 100 mcg CYT006-AngQb Healthy Volunteers

Biological: CYT006-AngQb
Experimental: 100 mcg CYT006-AngQb Hypertensives

Biological: CYT006-AngQb
Experimental: 300 mcg CYT006-AngQb Hypertensives

Biological: CYT006-AngQb
Placebo Comparator: Placebo Healthy Volunteers
Placebo Comparator: Placebo Hypertensives

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with untreated mild-to-moderate essential hypertension, clinically diagnosed according to the World Health Organization criteria (systolic blood pressure =140-179 mm Hg and/or diastolic blood pressure =90-109 mm Hg on 3 consecutive occasions; standardized after 5 minutes in sitting position)

    • Patients with newly diagnosed essential hypertension or previously treated patients from whom antihypertensive therapy can be safely withdrawn for the duration of the study.

    • 18 to 65 years of age, males and non-reproductive females (surgically sterilized or post-menopausal)

    • Written informed consent

    • Patient is willing and able to comply with all trial requirements

    Exclusion Criteria:

    • Secondary hypertension

    • Severe essential hypertension

    • Current pharmacological treatment that could affect blood pressure

    • Significant renal insufficiency [Serum creatinine > 159 µmol/L (> 1.8 mg/dl)]

    • History of cerebrovascular disease

    • Type 1 Diabetes or poorly controlled Type 2 Diabetes

    • Body mass index (BMI) >32

    • Total cholesterol > 6.9 mmol/L (> 266 mg/dl)

    • Triglycerides > 3.5 mmol/L ( > 174.3 mg/dl)

    • Autoimmune diseases or severe allergies

    • Patients with a history of HIV infection, AIDS, hepatitis B or C, or other immunosuppressive disorders

    • Current diagnosis or a history of malignancy

    • Drug or alcohol abuse within the past 2 years

    • Pregnancy or breastfeeding

    • Present history of mental diseases

    • Participation in any drug trial within three month of onset of current trial

    • Previous participation in a clinical trial with a Qb based vaccine (DerQb, NicQb, AllQb)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cytos Biotechnology AG

    Investigators

    • Principal Investigator: Frank D Wagner, MD, Parexel International, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cytos Biotechnology AG
    ClinicalTrials.gov Identifier:
    NCT00500786
    Other Study ID Numbers:
    • CYT006-AngQb 01
    First Posted:
    Jul 13, 2007
    Last Update Posted:
    Aug 21, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension

    Study Results

    No Results Posted as of Aug 21, 2012