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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2012-001757-21
    Sponsor's Protocol Code Number:ESH-CHL-SHOT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-31
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-001757-21
    A.3Full title of the trial
    European Society of Hypertension and Chinese Hypertension League stroke in hypertension optimal treatment trial
    Studio sul trattamento ottimale dell'ictus dell'iperteso della Societa' Europea dell'Ipertensione e della Lega Cinese contro l'Ipertensione
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal treatment for preventing recurrent stroke in hypertensives
    Trattamento ottimale per la prevenzione secondaria dello stroke nei pazienti ipertesi.
    A.3.2Name or abbreviated title of the trial where available
    Stroke in hypertension optimal treatment
    Trattamento ottimale dell'ictus nell'iperteso
    A.4.1Sponsor's protocol code numberESH-CHL-SHOT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01563731
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIstituto Auxologico Italiano
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Auxologico Italiano
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Ariosto, 13
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20145
    B.5.4Telephone number02.619112237
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNantipertensivi, statine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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. medicinal product typeMedicinali di sintesi chimica
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with arterial hypertension and previous stroke or transient ischemic attack
    Pazienti con ipertensione arteriosa e precedente stroke o attacco ischemico transitorio
    E.1.1.1Medical condition in easily understood language
    Hypertensive patients with previous cerebral vascular attack
    Pazienti ipertesi con precedente attacco vascolare cerebrale
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether in older adults with hypertension and a previous stroke or transient ischemic attack: 1) reduction in systolic blood pressure <125 mmHg is more effective in preventing recurrent stroke of a reduction in systolic blood pressure values ​​of <145-135 or <135 to 125 mmHg, or if the lowest values ​​of systolic pressure reduction of the benefits are minor; 2) a reduction of LDL-cholesterol to <1.8 mmol/L exerts a more effective prevention of down to values <2.8-1.8 mmol/L.
    Studiare se in ipertesi anziani con un precedente stroke o attacco ischemico transitorio: 1) la riduzione della pressione sistolica a &lt; 125 mmHg sia piu' efficace nel prevenire una recidiva di stroke di una riduzione della pressione sistolica a valori di &lt; 145-135 o di &lt; 135 a 125 mmHg, o se invece ai piu' bassi valori di pressione sistolica i benefici della riduzione della pressione siano minori; 2) una riduzione dell’LDL-colesterolo a valori &lt; 1.8 mmol/L eserciti una prevenzione piu' efficace che una riduzione a valori &lt; 2.8-1.8 mmol/L.
    E.2.2Secondary objectives of the trial
    Determine whether more or less intense reductions in systolic blood pressure and LDL-cholesterol are also effective on the incidence of other cardiovascular events, cognitive decline, dementia and neurological disabilities.
    Stabilire se riduzioni piu' o meno intense della pressione sistolica e dell’LDL-colesterolo siano pure efficaci sull’incidenza di altri eventi cardiovascolari,declino cognitivo,demenza e disabilita' neurologica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Stroke or transient ischemic attack 1 to 6 months previous to randomization; - 65 years and above; - Only hypertensive patients; - Patients without statin treatment with LDL-cholesterol > 2.8 mmol/l; - Patients on statin treatment with any LDL-cholesterol value
    - Ictus o attacco ischemico transitorio da 1 a 6 mesi precedenti la randomizzazione; - 65 anni e oltre; - Solo pazienti ipertesi; - Pazienti senza trattamento con statine con colesterolo LDL&gt; 2,8 mmol / l; - Pazienti in trattamento con statine con qualsiasi valore di LDL-colesterolo
    E.4Principal exclusion criteria
    - Patients in unstable clinical conditions; - Patients with haemodynamically significant carotid stenosis or requiring carotid revascularization.
    - Pazienti in condizioni cliniche instabili; - Pazienti con stenosi carotidea emodinamicamente significativa o che richiedono rivascolarizzazione carotidea.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is time to occurrence of (recurrent) stroke (fatal and nonfatal).
    L'endpoint primario e' il tempo fino all'insorgenza di ictus (ricorrente), (mortale e non mortale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of trial (mean follow-up period of 4 years)
    Durata del trial (follow up medio di 4 anni)
    E.5.2Secondary end point(s)
    A) Cardiovascular (major cardiovascular events, coronary events, death from any cause, cardiovascular death, hospitalized heart failure, etc.); B) neurological (cognitive defects, dementia)
    A) cardiovascolari (eventi cardiovascolari maggiori, eventi coronarici, morte di qualsiasi causa, morte cardiovascolare, insufficienza cardiaca ospedalizzata, ecc); B) neurologici (difetto cognitivo, demenza)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of trial (mean follow-up period of 4 years)
    Durata del trial (follow up medio di 4 anni)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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 Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Diversi obiettivi di pressione sistolica e LDL-C
    Different targets of SBP and LDL-C
    E.8.2.4Number of treatment arms in the trial5
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7500
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 7500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All subjects will be treated according to the strategies proved to be more beneficial
    Si consigliera' di trattare tutti i soggetti secondo le strategie che saranno risultate piu' vantaggiose
    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 Decision2013-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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