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

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ClinicalTrials.gov Identifier: NCT00500786
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG

Tracking Information
First Submitted Date  ICMJE July 12, 2007
First Posted Date  ICMJE July 13, 2007
Last Update Posted Date August 21, 2012
Study Start Date  ICMJE November 2004
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb
Official Title  ICMJE Not Provided
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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Biological: CYT006-AngQb
Study Arms  ICMJE
  • Experimental: 100 mcg CYT006-AngQb Healthy Volunteers
    Intervention: Biological: CYT006-AngQb
  • Experimental: 100 mcg CYT006-AngQb Hypertensives
    Intervention: Biological: CYT006-AngQb
  • Experimental: 300 mcg CYT006-AngQb Hypertensives
    Intervention: Biological: CYT006-AngQb
  • Placebo Comparator: Placebo Healthy Volunteers
  • Placebo Comparator: Placebo Hypertensives
Publications * Tissot AC, Maurer P, Nussberger J, Sabat R, Pfister T, Ignatenko S, Volk HD, Stocker H, Müller P, Jennings GT, Wagner F, Bachmann MF. Effect of immunisation against angiotensin II with CYT006-AngQb on ambulatory blood pressure: a double-blind, randomised, placebo-controlled phase IIa study. Lancet. 2008 Mar 8;371(9615):821-7. doi: 10.1016/S0140-6736(08)60381-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August¬†20,¬†2012)
88
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00500786
Other Study ID Numbers  ICMJE CYT006-AngQb 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cytos Biotechnology AG
Study Sponsor  ICMJE Cytos Biotechnology AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank D Wagner, MD Parexel International, Berlin, Germany
PRS Account Cytos Biotechnology AG
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP