<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255253</url>
  </required_header>
  <id_info>
    <org_study_id>2013BAI05B02</org_study_id>
    <nct_id>NCT02255253</nct_id>
  </id_info>
  <brief_title>Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population</brief_title>
  <official_title>Efficacy of Telmisartan 40mg and Hydrochlorothiazide 25mg Monotherapy in High Sodium Intake Patients With Mild to Moderate Hypertension: a Multicenter Randomized Double-blinded Parallel Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The George Institute for Global Health, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The George Institute for Global Health, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this research, the investigators aim to compare the antihypertensive efficacy and safety&#xD;
      of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic&#xD;
      Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.&#xD;
      The research will be conducted in the rural area in Hebei province, where people have a high&#xD;
      sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local&#xD;
      county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB&#xD;
      or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day&#xD;
      respectively. After two-month treatment, the investigators will evaluate and compare the&#xD;
      antihypertensive efficacy and safety between the two therapies.&#xD;
&#xD;
      The first objective of the research is to compare the antihypertensive efficacy of&#xD;
      monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic&#xD;
      Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate&#xD;
      hypertension.The second objective is to compare the safety between the two therapies applied.&#xD;
&#xD;
      Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure&#xD;
      between treating high sodium intake patients with mild to moderate hypertension with&#xD;
      telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy&#xD;
      differences of lowering the systolic pressure between treating high sodium intake patients&#xD;
      with mild to moderate hypertension with telmisartan and hydrochlorothiazide.&#xD;
&#xD;
      This research is a multicenter randomized double-blinded parallel controlled trial targeting&#xD;
      on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200&#xD;
      subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of&#xD;
      telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the&#xD;
      compliance of the patients will be followed after a week. The investigators will evaluate the&#xD;
      efficacy of blood pressure control and the safety of the medicines after one month and two&#xD;
      months of the beginning of therapies. Figure 1 shows the research process.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects</measure>
    <time_frame>2 months</time_frame>
    <description>We will measure the SBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects</measure>
    <time_frame>2 months</time_frame>
    <description>We will measure the DBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The between-group difference of the blood pressure control rates before and after the intervention of the subjects</measure>
    <time_frame>2 months</time_frame>
    <description>The patients whose SBP is less than 140 (150 for the old) and DBP less than 90 are thought to be controlled.</description>
  </other_outcome>
  <other_outcome>
    <measure>The between-group difference of the changing ranges of FBG testing results before and after the intervention of the subjects</measure>
    <time_frame>2 months</time_frame>
    <description>Blood samples will be collected at baseline and the end of 2-month intervention for FBG test.</description>
  </other_outcome>
  <other_outcome>
    <measure>The between-group difference of the incidence rates of hypokalemia after the intervention of the subjects</measure>
    <time_frame>2 months</time_frame>
    <description>Blood samples will be collected at baseline and the end of 2-month intervention for test</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1410</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Telmisartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>capsule,40mg per day,2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, 25mg per day, 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <description>capsule,40mg per day,2 months</description>
    <arm_group_label>Telmisartan</arm_group_label>
    <other_name>China Resources Double-crane Pharmaceutical Co., Ltd</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <description>tablet, 25mg per day, 2 months</description>
    <arm_group_label>Hydrochlorothiazide</arm_group_label>
    <other_name>Tianjin LiSheng Pharmaceutical Co., Ltd</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥18&#xD;
&#xD;
          -  Essential hypertension: systolic blood pressure (SBP) is between 140mmHg-179mmHg and&#xD;
             diastolic blood pressure (DBP)&lt;110mmHg OR DBP is between 90mmHg-109mmHg and&#xD;
             SBP&lt;180mmHg.&#xD;
&#xD;
          -  Hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).&#xD;
&#xD;
          -  Subjects are not using antihypertensive medicines or medicines which affect the blood&#xD;
             pressure within a week.&#xD;
&#xD;
          -  Subjects volunteer to be brought in the research and have signed informed consent&#xD;
             form, given that they have understood the research content.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are already pregnant, in lactation and intend to be pregnant.&#xD;
&#xD;
          -  Patients who have seriously allergic reaction or angioneurotic edema when taking ARB;&#xD;
             Patients who have allergic history of thiazide diuretic (HCTZ) or sulfonamides.&#xD;
&#xD;
          -  Patients who do not want to stop or have to take the medicines which are also&#xD;
             antihypertensive or affect the blood pressure, other than which provided by the&#xD;
             research.&#xD;
&#xD;
          -  Stroke or CHD patients who are diagnosed within 6 months. CHD patients are identified&#xD;
             by being diagnosed by coronary arteriography or coronary CT angiography, having&#xD;
             received coronary stent or coronary artery bypass surgery, or being diagnosed with&#xD;
             acute myocardial infarction. Stroke patients are identified by being diagnosed with&#xD;
             cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage&#xD;
             or transient ischemic attack.&#xD;
&#xD;
          -  Patients who are clearly diagnosed with following diseases: Congenital disease,&#xD;
             myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac&#xD;
             failure.&#xD;
&#xD;
          -  Patients who are clearly diagnosed with following symptoms or diseases: Proteinuria or&#xD;
             heavy proteinuria, renal insufficiency or serious renal function damage, hepatic&#xD;
             insufficiency or serious hepatic function damage; retinal exudates or hemorrhage, or&#xD;
             papilledema.&#xD;
&#xD;
          -  Patients who are clearly diagnosed with serious or deadly diseases in other systems.&#xD;
&#xD;
          -  Patients who get dementia or other serious diseases cannot cooperate with researchers.&#xD;
&#xD;
          -  Patients who drink 200g white spirits per day in past week.&#xD;
&#xD;
          -  Patients who meet other situations which are considered to be inappropriate to be&#xD;
             enrolled into the study by researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhang Pu Hong</last_name>
    <role>Principal Investigator</role>
    <affiliation>The George Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Traditional Medicine Hospital of Anguo</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boye hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lixian chinese traditional medicine hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaoyang hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071500</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's hospital in Rongcheng</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mancheng Hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>072150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shunping Hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>072250</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's hospital of Tangxian</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>072350</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wangdu hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>072450</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaobeidian hospital</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>074000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central hospital in Baigou</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>074004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second hospital of Lai Shui</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>074100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenan Hospital</name>
      <address>
        <city>Lanfang</city>
        <state>Hebei</state>
        <zip>065800</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dacheng chinese traditional medicine hospital</name>
      <address>
        <city>Langfang</city>
        <state>Hebei</state>
        <zip>065900</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The George Institute for Global Health, China</investigator_affiliation>
    <investigator_full_name>Puhong Zhang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Telmisartan</keyword>
  <keyword>Hydrochlorothiazide</keyword>
  <keyword>Efficacy</keyword>
  <keyword>hypertension</keyword>
  <keyword>high sodium intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255253
org study id: 2013BAI05B02
nct id: NCT02255253
lead sponsor: 
collaborator: 
has dmc: Yes
In this research, the investigators aim to compare the antihypertensive efficacy and safety
      of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic
      Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.
      The research will be conducted in the rural area in Hebei province, where people have a high
      sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local
      county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB
      or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day
      respectively. After two-month treatment, the investigators will evaluate and compare the
      antihypertensive efficacy and safety between the two therapies.

      The first objective of the research is to compare the antihypertensive efficacy of
      monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic
      Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate
      hypertension.The second objective is to compare the safety between the two therapies applied.

      Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure
      between treating high sodium intake patients with mild to moderate hypertension with
      telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy
      differences of lowering the systolic pressure between treating high sodium intake patients
      with mild to moderate hypertension with telmisartan and hydrochlorothiazide.

      This research is a multicenter randomized double-blinded parallel controlled trial targeting
      on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200
      subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of
      telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the
      compliance of the patients will be followed after a week. The investigators will evaluate the
      efficacy of blood pressure control and the safety of the medicines after one month and two
      months of the beginning of therapies. Figure 1 shows the research process.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects
time frame: 2 months
description: We will measure the SBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
measure: The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects
time frame: 2 months
description: We will measure the DBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
measure: The between-group difference of the blood pressure control rates before and after the intervention of the subjects
time frame: 2 months
description: The patients whose SBP is less than 140 (150 for the old) and DBP less than 90 are thought to be controlled.
measure: The between-group difference of the changing ranges of FBG testing results before and after the intervention of the subjects
time frame: 2 months
description: Blood samples will be collected at baseline and the end of 2-month intervention for FBG test.
measure: The between-group difference of the incidence rates of hypokalemia after the intervention of the subjects
time frame: 2 months
description: Blood samples will be collected at baseline and the end of 2-month intervention for test
arm group label: Telmisartan
arm group type: Experimental
description: capsule,40mg per day,2 months
arm group label: Hydrochlorothiazide
arm group type: Experimental
description: tablet, 25mg per day, 2 months
intervention type: Drug
intervention name: Telmisartan
description: capsule,40mg per day,2 months
arm group label: Telmisartan
other name: China Resources Double-crane Pharmaceutical Co., Ltd
intervention type: Drug
intervention name: Hydrochlorothiazide
description: tablet, 25mg per day, 2 months
arm group label: Hydrochlorothiazide
other name: Tianjin LiSheng Pharmaceutical Co., Ltd
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhang Pu Hong
role: Principal Investigator
affiliation: The George Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The George Institute for Global Health, China
investigator full name: Puhong Zhang
investigator title: Associate Professor
mesh term: Hypertension
mesh term: Hydrochlorothiazide
mesh term: Telmisartan