Safety and Efficacy Study of Angiotensin Therapeutic Vaccine in Subjects With Mild to Moderate Hypertension

NCT00702221 | Terminated Phase 2 Results DMC

• 1 other identifier: PR002-CLN-pro008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 12

Brief Summary

Angiotensin Therapeutic Vaccine (ATV), which contains the novel adjuvant, CoVaccine HT™ , is being developed for the treatment of high blood pressure (hypertension), a major risk factor for serious diseases such as heart attacks and strokes. Many patients with high blood pressure fail to take their medicines as prescribed because they generally feel well, which often results in poor control of the condition. As a result, it is estimated that about 70% patients with hypertension do not have their blood pressure adequately controlled despite advances in the treatment of high blood pressure. The main aim of this study is to find out if an injection of ATV given in the arm once every 3 weeks on 3 occasions results in lowering overall blood pressure measurements throughout the day. The other aims are to find out if ATV is safe and to see how well it is tolerated

Conditions

Hypertension; Cardiovascular Disease

Keywords

high blood pressure; vaccines

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)

  baseline to 8 weeks

Study Arms (2)

ATV with CoVaccine HT™

EXPERIMENTAL

Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)

Biological: Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant

CoVaccine HT™ adjuvant alone

PLACEBO COMPARATOR

CoVaccine HT™ adjuvant alone

Biological: CoVaccine HT™ adjuvant

Interventions

Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant BIOLOGICAL

Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant given as 3 separate intramuscular injections into the arm, 21 days apart

ATV with CoVaccine HT™

CoVaccine HT™ adjuvant BIOLOGICAL

Given as three separate intramuscular injections into the arm, 21 days apart

CoVaccine HT™ adjuvant alone

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent to provide written informed consent
• years old
• Body Mass Index (BMI) 19 to 33 kg/m2
• Mild to moderate hypertension per British Hypertension Society (BHS) Guidelines BHS-IV based on the following criteria of sitting blood pressure for subjects without diabetes or renal dysfunction.
• Average sitting morning DBP 90 to 109 mmHg and SBP 140 to 179 mmHg and have responded positively to a quinapril challenge.

You may not qualify if:

• Women of childbearing potential: defined to be not surgically sterile and \<2 y post-menopausal
• Average sitting SBP of \>180 mmHg or DBP of \>110 mmHg.
• A BP difference between left and right arm greater than 20 mmHg for SBP and 10 mmHg for DBP which is present on 3 consecutive readings.
• Left ventricular (LV) systolic dysfunction as evidenced by a known LV ejection fraction \<40% or symptomatic congestive heart failure requiring treatment.
• HbA1c \>7.0% or a history of Type 1 or Type 2 diabetes.
• Haemoglobin \<12 g/dL at Screening.
• Hypo- or hyperthyroidism
• Serum alanine aminotransferase or aspartate aminotransferase \>2X ULN.
• Other identifiable secondary causes of hypertension
• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of Screening.
• Bradycardia \<50 beats per minute at rest in the supine position prior to randomisation.
• Have sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), history of recurrent ventricular tachycardia, or symptomatic bradycardia.
• Implanted pacemakers or cardioverter defibrillator.
• Haemodynamically significant valvular heart disease.
• History of renal dysfunction and/or estimated glomerular filtration rate \<60 mL/min/1.73 m2.

Sponsors & Collaborators

• BTG International Inc.: lead
• Encorium: collaborator

Study Sites (12)

Fowey River Practice

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Alverton Practice

Penzance, Cornwall, TR18 4JH, United Kingdom

Location

Brannel Surgery

Saint Stephen, Cornwall, PL26 7RL, United Kingdom

Location

Saltash Health Centre

Saltash, Cornwall, PL12 6DL, United Kingdom

Location

Cape Cornwall Surgery

St Just, Cornwall, TR19 7HX, United Kingdom

Location

Avondale Surgery

Chesterfield, Derbyshire, S40 4FT, United Kingdom

Location

Knowle House Surgery

Plymouth, Devon, PL5 3JB, United Kingdom

Location

Layton Medical Centre

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Sherbourne Medical Centre

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Abbey Meads Medical Practice

Swindon, Wiltshire, SN25 4YZ, United Kingdom

Location

Grey Gable Surgery

Inkberrow, Worcestershire, WR7 4BW, United Kingdom

Location

The Acumen Pharmaceutical Services Ltd

Manchester, M50 2GY, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Limitations and Caveats

Study prematurely terminated

Results Point of Contact

• Title: SVP, Clinical Development
• Organization: BTG International Inc.

thomas.king@btgplc.com

610-278-1660

Study Officials

• Wajdi H Turkie, MD

  The Acumen Pharmaceuticals Services Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2010
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (12)