A Randomized, Double Blind, Placebo Controlled Study of the Efficacy and Safety of Angiotensin Therapeutic Vaccine (ATV) in Patients With Mild to Moderate Hypertensio

• Conditions: Men and women, 35-70 years old with mild to moderate Hypertension as classified by the British Hypertension Society (BHS) Guidelines - BHS-IV based on the following crietia of sitting blood pressure measured by spygomanography for patienst without diabetes or renal dysfunction:Grade 1 (mild): Systolic BP 140-159 mmHG and Diastolic BP of 90-99 mmHgGrade 2 (moderate): Systolic BP 160-179 mmHg and Diastolic BP 100-109 mmHg; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension; MedDRA version: 9.1Level: PTClassification code 10020772Term: Hypertension; MedDRA version: 9.1Level: PTClassification code 10042957Term: Systolic hypertension; MedDRA version: 9.1Level: PTClassification code 10012758Term: Diastolic hypertension

• Registration Number: EUCTR2008-001001-41-GB
• Lead Sponsor: Protherics Medicines Development Ltd, a BTG plc company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects must be competent to provide written informed consent. Subjects must sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form (ICF). Authorization must also be obtained prior to the initiation of any study procedures.
2. Subjects must be 35-70 years of age.
3. Subjects must have a Body Mass Index (BMI) of 19 to 35 kg/m2, inclusive.
4. At baseline (Day -1), subjects must have mild to moderate hypertension as classified by the British Hypertension Society (BHS) Guidelines – BHS-IV based on the following criteria of sitting blood pressure measured by sphygmomanometry for subjects without diabetes or renal dysfunction.
Systolic BP (SBP)Diastolic BP (DBP)
Grade 1140 – 159 mmHg90 – 99 mmHg
Grade 2160 – 179 mmHg100 – 109 mmHg
5. At baseline (Day -1), all subjects must have an average sitting morning DBP 90 to 109 mmHg (inclusive) and SBP 140 to 179 mmHg (inclusive) as measured by sphygmomanometry and have responded positively to a quinapril challenge in order to enter the study. No subject will be eligible for the study if his/her SBP is >180 mmHg any time during the Screening Period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have failed the quinapril challenge.
2. Women of childbearing potential will be excluded from study participation. Women who are surgically sterile or are documented to have been post-menopausal for at least 2 years will be considered for study participation. Post-menopausal female subjects who are <60 years of age and who are not surgically sterile will be required to use a double-barrier method of birth control during the Treatment Period and Follow-up Period until their anti-angiotensin IgG titres approximates the subject’s baseline levels.
3. Subjects with an average sitting SBP of >180 mmHg or DBP of >110 mmHg.
4. Subjects with a BP difference between left and right arm on screening greater than 20 mmHg for SBP and 10 mmHg for DBP which is present on 3 consecutive readings.
5. Subjects with left ventricular (LV) systolic dysfunction as evidenced by a known LV ejection fraction <40% or symptomatic congestive heart failure (CHF) requiring treatment.
6. Subjects with a HbA1c >7.0% at Screening or a history of Type 1 or Type 2 diabetes.
7. Subjects who have a haemoglobin <12 g/dL at Screening.
8. Subjects with hypo- or hyperthyroidism, as evidenced by a serum thyroid stimulating hormone (TSH) concentration that is greater than one-times the upper limit of normal (ULN) or less than the lower limit of normal (LLN) at Screening.
9. Subjects with a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X ULN at Screening.
10. Subjects with other identifiable secondary causes of hypertension (eg, parathyroid disease, pheochromocytoma, Cushing’s disease, hyperaldosteronism, aortic coarctation). On Screening, if the difference between BP measured on the right and left arm is greater than 20 mmHg for SBP and 10 mmHg for DBP and are present on 3 consecutive readings, the subject will be excluded from the study.
11. Subjects who have experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of Screening.
12. Bradycardia <50 beats per minute at rest in the supine position prior to randomisation.
13. Subjects with sick sinus syndrome or second or third degree atrioventricular (AV) block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), a history of recurrent ventricular tachycardia, or symptomatic bradycardia.
14. Subjects with implanted pacemakers or an implanted cardioverter defibrillator (ICD).
15. Subjects with hemodynamically significant valvular heart disease.
16. Subjects with a history of renal dysfunction and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening.18
17. Subjects who have had a diagnosis or recurrence of malignancy within the past 3 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix.
18. Subjects with sleep apnea are excluded unless a recent (within 30 days of Screening) sleep study demonstrates no recordings of arterial oxygen saturation (SaO2) <90%, treated or untreated, at any time during the Screening Period.
19. Subjects who perform alternating shift or night work.
20. Subjects not on stable doses of all concomitant medications for a minimum of 4 weeks prior to Screening, and subjects treated with any of the following prohibited medications:
a. Oral corticosteroids within 3 months of Screening.
b. Acetylsalicylic acid in excess of 325 mg per day.
c. Chronic stable or unstable use of non-ste

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified