<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200723048182N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Captopril and Carvedilol in Hypertension Urgency.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison and Evaluation of the Effect of Oral Captopril and Carvedilol in Patients with Hypertension Urgency.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: If the inclusion criteria are met and blood pressure does not decrease after 20 minutes of bed rest, patients will be divided into two groups with Random block method: A (taking captopril 25 mg orally) and group B (taking carodilol 6.25 mg orally).Randomization will be done by Random Allocation software, Blinding description: If the inclusion criteria are met and blood pressure does not decrease after 20 minutes ,after randomization by block method and placing patients in two groups A and B.In order to eliminate the bias caused by the patient's awareness and the health care provider (who is responsible for giving the capsule to the patient and measuring and recording information from the beginning of the study) to the type of treatment received and its possible impact on the results,The study will be conducted in double blind study, therefore Captopril and carvedilol tablets are placed in the same capsules so that the patient and the health care provider are not informed about the type of medication received.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Taking captopril 25 mg orally and in a single dose. Intervention 2: Intervention group: Taking carodilol 6.25 mg orally and in a single dose.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Razavianzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al-Anbia Hospital, Daneshgah Blv</address>
        <city>Sharoud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36148-71151</zip>
        <telephone>+98 23 3233 9661</telephone>
        <email>nasrinrazavianzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>nasrin razavianzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al-Anbia Hospital, Daneshgahi Blv</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36148-71151</zip>
        <telephone>+98 23 3233 9661</telephone>
        <email>nasrinrazavianzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Refer to the hospital emergency department with symptoms of blood pressure equal to or greater than 160/90 mmHg in patients with hypertension or blood pressure equal to or greater than 180/110 mmHg in patients with new onset of the disease in the age range of 18 to 65 years.
Obtaining written consent from patients.
Complete the file and information contained in the questionnaire form.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to obtain written consent from patients
Defects in the file and information contained in the questionnaire form
Patients with acute chest pain
Bradycardia
History of heart block or sick sinus syndrome
Irreversible heart failure
Pulmonary edema
Aortic dissection
Patients who need intravenous drugs to control blood pressure or require high doses of ACEIs and ARBs (captopril&gt; 50 mg / d, enalapril&gt; 10 mg / d, lisinopril&gt; 5 mg / d, losartan&gt; 50 mg / d, valsartan &gt; 80 mg / d).
Loss of consciousness
Seizure
Cerebrovascular accidents (ischemia or bleeding)
Acute or chronic renal failure
Previous history of pheochromocytoma
History of bilateral renal artery stenosis
Pregnancy
Hypertension after surgery
Diastolic blood pressure above 120
History of allergies to captopril and carvedilol and allergies to penicillin and sulfonamides.
Asthma or other bronchospasm diseases
Existence of cardiogenic shock
Severe liver failure
Papillary edema
Anuria</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Taking captopril 25 mg orally and in a single dose</i_keyword>
      <i_keyword>Intervention group: Taking carodilol 6.25 mg orally and in a single dose</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: In 10, 20, 30, 45, 60, 90, 120 and 180 minutes after drug administration. Method of measurement: With a hand pressure gauge and with a scale of millimeters of mercury.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: In 10, 20, 30, 45, 60, 90, 120 and 180 minutes after drug administration. Method of measurement: With a hand pressure gauge and with a scale of millimeters of mercury.</prim_outcome>
      <prim_outcome>Mean blood pressure. Timepoint: In 10, 20, 30, 45, 60, 90, 120 and 180 minutes after drug administration. Method of measurement: After measuring systolic and diastolic blood pressure  its measured with the sum of twice the diastolic blood pressure and the systolic blood pressure divided by three ((2DBP + SBP)/3) will be calculated.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: In 10, 20, 30, 45, 60, 90, 120 and 180 minutes after drug administration. Method of measurement: By counting the number of radial pulses.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction rate. Timepoint: At intervals and ends of measurements. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: At intervals and ends of measurements. Method of measurement: questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sina Sarchahi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-03</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of semnan</contact_name>
        <contact_address>Islamic Azad University of semnan Complex, Daneshgahi Town, semnan semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
