NCT00710372

A Double Blind, Randomized, Placebo Controlled, Parallel Group, Dose-Titration Phase II Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension

Completed Phase 2 Last updated 11 November 2010

What this trial tests

Phase 2 trial testing CYT006-AngQb in Mild Essential Hypertension in 83 participants. Completed in 1 November 2010.

Timeline

1 June 2008

Primary endpoint
1 July 2009

1 November 2010

Quick facts

Lead sponsor	Cytos Biotechnology AG
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	83
Start date	1 June 2008
Primary completion	1 July 2009
Estimated completion	1 November 2010
Sites	1 location across Switzerland

Drugs / interventions tested

• CYT006-AngQb — full drug profile →

Conditions studied

• Mild Essential Hypertension — all drugs for Mild Essential Hypertension →
• Moderate Essential Hypertension — all drugs for Moderate Essential Hypertension →

Sponsor

Cytos Biotechnology AG — full company profile →

Who can join

Adults 18 to 69, any sex, with Mild Essential Hypertension or Moderate Essential Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Adverse events: quality, quantity, severity
  Time frame: throughout complete study until week 48

Sponsor's own description

The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This form of presenting Ang II to the immune system induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against angiotensin II may offer a valuable alternative to conventional drugs for the treatment of hypertension.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomaterial-assisted biotherapy: A brief review of biomaterials used in drug delivery, vaccine development, gene therapy, and stem cell therapy.
   Han X, Alu A, Liu H, Shi Y, et al · · 2022 · cited 87× · PMID 35386442 · DOI 10.1016/j.bioactmat.2022.01.011
2. The renin-angiotensin system biomolecular cascade: a 2022 update of newer insights and concepts.
   Ferrario CM, Groban L, Wang H, Sun X, et al · · 2022 · cited 32× · PMID 35529089 · DOI 10.1016/j.kisu.2021.11.002
3. Recent Review on Biological Barriers and Host-Material Interfaces in Precision Drug Delivery: Advancement in Biomaterial Engineering for Better Treatment Therapies.
   Deshmukh R, Sethi P, Singh B, Shiekmydeen J, et al · · 2024 · cited 18× · PMID 39204421 · DOI 10.3390/pharmaceutics16081076
4. Senolytic Vaccines from the Central and Peripheral Tolerance Perspective.
   Vasilieva MI, Shatalova RO, Matveeva KS, Shindyapin VV, et al · · 2024 · cited 1× · PMID 39772050 · DOI 10.3390/vaccines12121389