<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/NCT02217852</url>
  </required_header>
  <id_info>
    <org_study_id>WestChinaH 20140701</org_study_id>
    <nct_id>NCT02217852</nct_id>
  </id_info>
  <brief_title>Treatment of Hypertension in Tibetan Adult Population</brief_title>
  <official_title>A Randomized, Open-label, Positive Drug Controlled Clinical Trials to Compare the Efficacy of Nitrendipine and Hydrochlorothiazide , Captopril Plus Hydrochlorothiazide and Beijing Hypotensive No.0 in Tibetan Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several surveys had revealed that Tibetan adults had high prevalence of hypertension.&#xD;
      However, there was no research studying the antihypertensive effect of the known drugs in&#xD;
      Tibetan. The main arms of our study were to determine if the efficacy of lowing blood&#xD;
      pressure and protecting target organ damage differs between nitrendipine and&#xD;
      Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of&#xD;
      lowing blood pressure and protecting target organ damage differs between captopril plus&#xD;
      Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several surveys had revealed that Tibetan adults had high blood pressure(BP)and prevalence of&#xD;
      hypertension than other parts of China and were also higher than those in developed nations&#xD;
      as well. For example, one study found that among Tibetan herdsmen 40 years and older, the&#xD;
      prevalence of hypertension was 56% and the mean systolic blood pressure/diastolic blood&#xD;
      pressure was 146.6/92.0mmHg. However, the rates of awareness, treatment, and control were&#xD;
      dismally low.&#xD;
&#xD;
      The Tibetan have been living in the Tibetan Plateau. The special natural and social&#xD;
      environment there，as well as ethnic ,may all be involved in the etiology of the high&#xD;
      prevalence and effect the response to antihypertensive treatment. Nevertheless, few&#xD;
      interventional studies have been done in Tibetan hypertensive patients. Therefore, the&#xD;
      purpose of our study was to compare the blood pressure reduction between different&#xD;
      antihypertensive drugs. Nitrendipine, hydrochlorothiazide, captopril and Beijing hypotensive&#xD;
      No.0 (also named&quot; compound hypotensive tablet&quot;) are selected, which are cheap and available&#xD;
      in the Tibetan Plateau.&#xD;
&#xD;
      Nitrendipine, hydrochlorothiazide and captopril are the representatives of Dihydropyridines&#xD;
      Calcium antagonists, diuretics, and angiotensin-converting enzyme inhibitors, respectively.&#xD;
      They are all recommended as the first-line antihypertensive drug. Beijing hypotensive No.0 is&#xD;
      produce by China Resources Double-crane Pharmaceutical company in China, and it is a&#xD;
      fixed-dose combination containing reserpine 0.1mg, hydrochlorothiazide 12.5mg, dihydralazine&#xD;
      sulfate 12.5mg, triamterene 12.5mg. Many studies conducted in China have demonstrated its&#xD;
      efficacy and safety in lowing blood pressure.&#xD;
&#xD;
      After recruitment, participant will be grouped according to their BP. If BP&lt;160/100mmHg,&#xD;
      monotherapy is started. Patient is randomly assigned to receive nitrendipine 10mg bid or&#xD;
      Hydrochlorothiazide 12.5mg qd. If BP≥160/100mmHg, Patient is randomly assigned to receive two&#xD;
      drug combination therapy(captopril 25mg three times daily (tid) and Hydrochlorothiazide&#xD;
      12.5mg qd) or Beijing hypotensive No.0 one pile qd. During the following 12 months，each&#xD;
      participant will take at least four visits at 1、3、6 and 12 months respectively. Goal BP for&#xD;
      all participants was less than 140/90mmHg, achieved by titrating the assigned study drug and&#xD;
      adding open-label agents when necessary. The maximum dosage is 20mg BID for nitrendipine,&#xD;
      25mg qd for Hydrochlorothiazide and 50mg tid for captopril. The dosage of Beijing hypotensive&#xD;
      No.0 should not be added.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Blood Pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of target organ damage</measure>
    <time_frame>12 months</time_frame>
    <description>Change of target organ damage(including estimated glomerular filtration rate, microalbuminuria, carotid intima-media thickness, arterial stiffness, left ventricular mass index) from baseline to study end at 12 months.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>A1 nitrendipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and nitrendipine will be added (dose range 10mg-20mg bid).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A2 hydrochlorothiazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and hydrochlorothiazide will be added (dose range 12.5mg-25mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1 captopril plus Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and captopril plus Hydrochlorothiazide will be added (dose range：captopril 25mg-50mg tid, Hydrochlorothiazide 12.5mg-25mg qd).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2 Beijing hypotensive No.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and Beijing hypotensive will be added (dose range：Beijing hypotensive No.0 one pile qd or less ).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrendipine</intervention_name>
    <description>doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.</description>
    <arm_group_label>A1 nitrendipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <description>doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.</description>
    <arm_group_label>A2 hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Captopril,Hydrochlorothiazide</intervention_name>
    <description>doses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance.</description>
    <arm_group_label>B1 captopril plus Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beijing hypotensive No.0</intervention_name>
    <description>1 pile po qd or less. Total duration would be until completion or study or medication intolerance.</description>
    <arm_group_label>B2 Beijing hypotensive No.0</arm_group_label>
    <other_name>compound hypotensive tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult Tibetan, who have been living in the Tibetan Plateau since he/she was born.&#xD;
&#xD;
          2. Consistent with diagnosed hypertension, blood pressure, for 1-3 grade.&#xD;
&#xD;
          3. Aged 18-80 years old.&#xD;
&#xD;
          4. To sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diagnosis of secondary hypertension&#xD;
&#xD;
          2. Hypertensive emergencies and urgencies&#xD;
&#xD;
          3. Malignant hypertension&#xD;
&#xD;
          4. Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine&gt;&#xD;
             133μmol / L.&#xD;
&#xD;
          5. Suffering from congenital heart disease, rheumatic heart disease, hypertrophic&#xD;
             cardiomyopathy, aortic stenosis.&#xD;
&#xD;
          6. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA),&#xD;
             unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty&#xD;
             (PTCA).&#xD;
&#xD;
          7. clinical significance of arrhythmia&#xD;
&#xD;
          8. Active liver disease, history of chronic persistent hepatitis, alanine&#xD;
             aminotransferase（ALT）&gt; upper limit of normal.&#xD;
&#xD;
          9. Pregnancy, pregnancy or breast-feeding women to prepare.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoping Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoping Chen, MD</last_name>
    <phone>86-028-85422175</phone>
    <email>xiaopingchen11@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Xiaoping Chen</investigator_full_name>
    <investigator_title>Deputy director of Department of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>Tibetan</keyword>
  <keyword>Nitrendipine</keyword>
  <keyword>hydrochlorothiazide</keyword>
  <keyword>captopril</keyword>
  <keyword>Beijing hypotensive No.0</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>Captopril</mesh_term>
    <mesh_term>Antihypertensive Agents</mesh_term>
    <mesh_term>Nitrendipine</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/NCT02217852
org study id: WestChinaH 20140701
nct id: NCT02217852
lead sponsor: 
has dmc: Yes
Several surveys had revealed that Tibetan adults had high prevalence of hypertension.
      However, there was no research studying the antihypertensive effect of the known drugs in
      Tibetan. The main arms of our study were to determine if the efficacy of lowing blood
      pressure and protecting target organ damage differs between nitrendipine and
      Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of
      lowing blood pressure and protecting target organ damage differs between captopril plus
      Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.
Several surveys had revealed that Tibetan adults had high blood pressure(BP)and prevalence of
      hypertension than other parts of China and were also higher than those in developed nations
      as well. For example, one study found that among Tibetan herdsmen 40 years and older, the
      prevalence of hypertension was 56% and the mean systolic blood pressure/diastolic blood
      pressure was 146.6/92.0mmHg. However, the rates of awareness, treatment, and control were
      dismally low.

      The Tibetan have been living in the Tibetan Plateau. The special natural and social
      environment there，as well as ethnic ,may all be involved in the etiology of the high
      prevalence and effect the response to antihypertensive treatment. Nevertheless, few
      interventional studies have been done in Tibetan hypertensive patients. Therefore, the
      purpose of our study was to compare the blood pressure reduction between different
      antihypertensive drugs. Nitrendipine, hydrochlorothiazide, captopril and Beijing hypotensive
      No.0 (also named" compound hypotensive tablet") are selected, which are cheap and available
      in the Tibetan Plateau.

      Nitrendipine, hydrochlorothiazide and captopril are the representatives of Dihydropyridines
      Calcium antagonists, diuretics, and angiotensin-converting enzyme inhibitors, respectively.
      They are all recommended as the first-line antihypertensive drug. Beijing hypotensive No.0 is
      produce by China Resources Double-crane Pharmaceutical company in China, and it is a
      fixed-dose combination containing reserpine 0.1mg, hydrochlorothiazide 12.5mg, dihydralazine
      sulfate 12.5mg, triamterene 12.5mg. Many studies conducted in China have demonstrated its
      efficacy and safety in lowing blood pressure.

      After recruitment, participant will be grouped according to their BP. If BP<160/100mmHg,
      monotherapy is started. Patient is randomly assigned to receive nitrendipine 10mg bid or
      Hydrochlorothiazide 12.5mg qd. If BP≥160/100mmHg, Patient is randomly assigned to receive two
      drug combination therapy(captopril 25mg three times daily (tid) and Hydrochlorothiazide
      12.5mg qd) or Beijing hypotensive No.0 one pile qd. During the following 12 months，each
      participant will take at least four visits at 1、3、6 and 12 months respectively. Goal BP for
      all participants was less than 140/90mmHg, achieved by titrating the assigned study drug and
      adding open-label agents when necessary. The maximum dosage is 20mg BID for nitrendipine,
      25mg qd for Hydrochlorothiazide and 50mg tid for captopril. The dosage of Beijing hypotensive
      No.0 should not be added.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Blood Pressure
time frame: 12 months
description: Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.
measure: Change of target organ damage
time frame: 12 months
description: Change of target organ damage(including estimated glomerular filtration rate, microalbuminuria, carotid intima-media thickness, arterial stiffness, left ventricular mass index) from baseline to study end at 12 months.
arm group label: A1 nitrendipine
arm group type: Experimental
description: this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and nitrendipine will be added (dose range 10mg-20mg bid).
arm group label: A2 hydrochlorothiazide
arm group type: Experimental
description: this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and hydrochlorothiazide will be added (dose range 12.5mg-25mg)
arm group label: B1 captopril plus Hydrochlorothiazide
arm group type: Experimental
description: this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and captopril plus Hydrochlorothiazide will be added (dose range：captopril 25mg-50mg tid, Hydrochlorothiazide 12.5mg-25mg qd).
arm group label: B2 Beijing hypotensive No.0
arm group type: Experimental
description: this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and Beijing hypotensive will be added (dose range：Beijing hypotensive No.0 one pile qd or less ).
intervention type: Drug
intervention name: Nitrendipine
description: doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.
arm group label: A1 nitrendipine
intervention type: Drug
intervention name: Hydrochlorothiazide
description: doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.
arm group label: A2 hydrochlorothiazide
intervention type: Drug
intervention name: Captopril,Hydrochlorothiazide
description: doses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance.
arm group label: B1 captopril plus Hydrochlorothiazide
intervention type: Drug
intervention name: Beijing hypotensive No.0
description: 1 pile po qd or less. Total duration would be until completion or study or medication intolerance.
arm group label: B2 Beijing hypotensive No.0
other name: compound hypotensive tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaoping Chen, MD
role: Principal Investigator
affiliation: West China Hospital
last name: Xiaoping Chen, MD
phone: 86-028-85422175
email: xiaopingchen11@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Xiaoping Chen
investigator title: Deputy director of Department of Internal Medicine
mesh term: Hypertension
mesh term: Hydrochlorothiazide
mesh term: Captopril
mesh term: Antihypertensive Agents
mesh term: Nitrendipine