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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00500786
First received: July 12, 2007
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Essential Hypertension
 Biological: CYT006-AngQb
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:

Enrollment: 88
Study Start Date: November 2004
Study Completion Date: April 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500786

Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Principal Investigator: Frank D Wagner, MD Parexel International, Berlin, Germany
  More Information

Additional Information:
Sponsor's web page  This link exits the ClinicalTrials.gov site

No publications provided by Cytos Biotechnology AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00500786     History of Changes
Other Study ID Numbers: CYT006-AngQb 01
Study First Received: July 12, 2007
Last Updated: August 20, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013