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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-001001-41
    Sponsor's Protocol Code Number:PR002-CLN-pro008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-04-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-001001-41
    A.3Full title of the trial
    A Randomized, Double Blind, Placebo Controlled Study of the Efficacy and Safety of Angiotensin Therapeutic Vaccine (ATV) in Patients With Mild to Moderate Hypertension
    A.4.1Sponsor's protocol code numberPR002-CLN-pro008
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorProtherics Medicines Development Ltd, a BTG plc company
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAngiotensin Therapeutic Vaccine (ATV) conjugate
    D.3.2Product code PMD3117
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePMD3117
    D.3.9.3Other descriptive nameAngiotensin Therapeutic Vaccine (ATV) conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCoVaccine HT adjuvant
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCoVaccine HT
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typecontains squalane (olive-derived)
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 mmHg
    Grade 2 (moderate): Systolic BP 160-179 mmHg and Diastolic BP 100-109 mmHg
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10042957
    E.1.2Term Systolic hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10012758
    E.1.2Term Diastolic hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Primary efficaccy objective of this study is to determine if immunization with ATV is effective in reducing mean daytime DBP measured by ambulatory blood pressure monitoring (ABPM) in subjects with mild to moderate hypertension.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to examine the effect of immunization with ATV on:
    • Mean 24-hour SBP measured by ABPM
    • Mean 24-hour DBP measured by ABPM
    • Mean sitting and standing morning DBP and SBP measured by sphygmomanometry
    • Mean morning DBP and SBP, daytime SBP, and night-time DBP and SBP measured by ABPM
    • Percent of subjects meeting DBP and SBP treatment target goals as measured by sphygmomanometry

    Safety Objectives
    To assess the local and systemic safety and tolerability of immunization with ATV in the study population.

    Immunological Objective
    To evaluate the immunogenicity of the ATV as measured by anti-angiotensin IgG titres.

    Additional Measures of Interest
    Aldosterone (serum) and active renin (plasma) concentrations, immune complex formation as well as other pharmacologic and/or immunologic measures.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 1 140 – 159 mmHg 90 – 99 mmHg
    Grade 2 160 – 179 mmHg 100 – 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.
    E.4Principal 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-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid is prohibited. For all subjects requiring analgesic or anti-pyretic agents, the use of paracetamol is recommended during study participation.
    d. Selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine reuptake inhibitors (SSNRIs).
    e. Tricyclic antidepressants (TCAs).
    f. Any angiotensin vaccine, including prior exposure to ATV.
    21. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks of Screening.
    22. Subjects who have any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit the subject’s lifespan or ability to complete the study
    23. Any major contraindication to stopping antihypertension medications for a period of up to 14 weeks.
    24. Subjects who have had previous exposure to CoVaccine HT adjuvant, or other keyhole limpet haemocyanin-containing vaccines.
    25. Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis.
    26. Subjects with a known history of drug and/or alcohol abuse and those known to be hepatitis positive.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change from baseline to Week 8 in mean daytime DBP measured by ABPM.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    placebo + adjuvant
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state124
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-06-01
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