<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/NCT03254446</url>
  </required_header>
  <id_info>
    <org_study_id>CT/P015/CMR/16/03_01</org_study_id>
    <nct_id>NCT03254446</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension</brief_title>
  <official_title>A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects With Diabetes, Dyslipidemia and Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Torrent Pharmaceuticals Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Torrent Pharmaceuticals Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The phase III trial is designed with an aim of determining the efficacy of Investigational&#xD;
      Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e.,&#xD;
      HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel&#xD;
      group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study&#xD;
      subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to&#xD;
      their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TRC150094 is an Investigational Product for the treatment of CV risk associated with&#xD;
      non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by&#xD;
      increasing the energy expenditure and restoring mitochondrial flexibility which is deranged&#xD;
      in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful&#xD;
      benefits in well-established contributors of CV risk i.e., insulin resistance and&#xD;
      hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP,&#xD;
      over and above standard of care.&#xD;
&#xD;
      The phase III trial is designed with an aim of determining the efficacy of TRC150094 in&#xD;
      concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL&#xD;
      cholesterol. This study will be a randomized, double blind, parallel group, placebo&#xD;
      controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will&#xD;
      receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard&#xD;
      of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.&#xD;
&#xD;
      Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving&#xD;
      cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary&#xD;
      Objectives of the study are,&#xD;
&#xD;
        1. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension&#xD;
&#xD;
        2. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in&#xD;
           subjects with diabetes, dyslipidemia and hypertension&#xD;
&#xD;
      In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in MAP</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in MAP from baseline to 24 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in non-HDL cholesterol</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in HbA1c from baseline to 24 weeks of treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in weight</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Mean change in weight from baseline to 24 weeks of treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety profile of TRC150094</measure>
    <time_frame>50 Weeks</time_frame>
    <description>The safety profile of TRC150094 beyond 24 weeks of treatment shall also be reported</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1250</enrollment>
  <condition>Diabetes</condition>
  <condition>Dyslipidemias</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>TRC150094 45 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching Placebo Tablet to be administered orally once a day for 50 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TRC150094</intervention_name>
    <description>TRC150094 Tablet 45 mg</description>
    <arm_group_label>TRC150094 45 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo Tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects in the age range 30-70 years (both inclusive)&#xD;
&#xD;
          2. BMI in the range 23-39 (inclusive) kg/m2&#xD;
&#xD;
          3. HbA1C ≥7.5 %&#xD;
&#xD;
          4. Stable therapy of ≤2 oral hypoglycemic agents for at least two months prior to&#xD;
             screening at doses that are appropriate for the duration of the study in the judgment&#xD;
             of the investigator.&#xD;
&#xD;
          5. Non HDL-cholesterol ≥ 160 mg/dL.&#xD;
&#xD;
          6. Mean Arterial Pressure (MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood&#xD;
             pressure monitoring (ABPM) with or without antihypertensive treatment (subjects will&#xD;
             have to be on stable dose of anti-hypertensive treatment for at least two months prior&#xD;
             to screening); Dose should be appropriate for the duration of the study in the&#xD;
             judgment of the investigator.&#xD;
&#xD;
          7. Willing to give written informed consent&#xD;
&#xD;
          8. Ability to adhere to the study restrictions and assessments schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of&#xD;
             24 hours' ambulatory blood pressure monitoring.&#xD;
&#xD;
          2. HbA1C &gt; 10 % at screening.&#xD;
&#xD;
          3. Serum triglycerides &gt;400 mg/dL.&#xD;
&#xD;
          4. LDL-cholesterol &gt;300 mg/dL or medical history/clinical evidence of familial&#xD;
             hyperlipidemic disorder.&#xD;
&#xD;
          5. Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.&#xD;
&#xD;
          6. Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.&#xD;
&#xD;
          7. Subjects having untreated thyroid dysfunction (TSH &lt;0.3 or &gt;5.5 µIU/mL) or hormone&#xD;
             related obesity disorder.&#xD;
&#xD;
          8. Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.&#xD;
&#xD;
          9. eGFR &lt;30 mL/min as evaluated by Modification of Diet in Renal Disease (MDRD) method.&#xD;
&#xD;
         10. Seropositive for HIV, Hepatitis B or Hepatitis C.&#xD;
&#xD;
         11. History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder,&#xD;
             malignancy in last 3 years.&#xD;
&#xD;
         12. Pregnant or lactating women.&#xD;
&#xD;
         13. Female of childbearing potential, who are neither surgically sterilized nor willing to&#xD;
             use reliable contraceptive methods (double barrier methods or intrauterine device).&#xD;
&#xD;
         14. Male subjects with partners of childbearing potential not willing to use reliable&#xD;
             contraception methods.&#xD;
&#xD;
         15. Clinically significant abnormal physical findings, laboratory results, ECG findings&#xD;
             and/or any other clinical observation or history during the screening examination,&#xD;
             which would interfere with the objectives of the study.&#xD;
&#xD;
         16. Intake of any investigational drug within 3 months prior to the first dose of study&#xD;
             drug.&#xD;
&#xD;
         17. In the opinion of the investigator, subject is unable to cooperate with any study&#xD;
             procedures, unlikely to adhere to the study procedures, keep appointments, or plan to&#xD;
             relocate during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikhil Tandon, M.D., PhD</last_name>
    <role>Study Chair</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shohini Ghosh, PhD</last_name>
    <phone>+91-79-23969100</phone>
    <phone_ext>574</phone_ext>
    <email>shohinighosh@torrentpharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Girish Deshmukh, PhD</last_name>
    <phone>+91-79-23969100</phone>
    <phone_ext>602</phone_ext>
    <email>girishdeshmukh@torrentpharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Comitê de ética em Pesquisa do Hospital Pró Cardíaco</name>
      <address>
        <city>Rio De Janeiro</city>
        <state>Botafogo</state>
        <zip>22270-005</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Augusto Russo, MD PhD, MBA</last_name>
      <phone>55 21 99988 0336</phone>
    </contact>
    <contact_backup>
      <last_name>Joselita S Bodart, MD, Physian</last_name>
      <phone>55 21 986961073</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Avenida Angélica</name>
      <address>
        <city>São Paulo</city>
        <state>CEP</state>
        <zip>01228-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Freddy G Eliaschewitz, Endocrino</last_name>
      <phone>55 11 27110298</phone>
      <email>freddy.g@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Denise R Franco, Endocrino</last_name>
      <phone>55 11 27110298</phone>
      <email>d9franco@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rua Silva Jardim</name>
      <address>
        <city>São Bernardo Do Campo</city>
        <state>SP</state>
        <zip>09715-090 -</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia M de Brito, MD, Physian</last_name>
      <phone>55 11 95369-9341</phone>
    </contact>
    <contact_backup>
      <last_name>Andrea S Audi, MD, Physian</last_name>
      <phone>55 11 95369-9341</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS</name>
      <address>
        <city>Canoas</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristiano P Jaeger, cardiologist</last_name>
      <phone>55 51 3478-8152</phone>
      <email>cristianojaeger@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Patricia E Pizzato, Cardiologist</last_name>
      <phone>55 51 3478-8152</phone>
      <email>patipizzato@hotmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rua Coronel Aureliano de Camargo,905, Centro,</name>
      <address>
        <city>Tatuí</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wladmir F Saporito, Cardiologist</last_name>
      <phone>55 15 3451-1300</phone>
      <email>wfsaporito@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Roberto S Almeida, cardiologist</last_name>
      <phone>55 15 3451-1300</phone>
      <phone_ext>219</phone_ext>
      <email>robertocardiologia@hotmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>BAPS Pramukh Swami Hospital,</name>
      <address>
        <city>Sūrat</city>
        <state>Gujarat</state>
        <zip>395009</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Parshottam Koradia, MBBS, MD</last_name>
      <phone>9825312027</phone>
      <email>purushottam_koradia@yahoo.co.in</email>
    </contact>
    <contact_backup>
      <last_name>Dr. Anand Modi, DNB</last_name>
      <phone>9825312027</phone>
      <email>purushottam_koradia@yahoo.co.in</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Bangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560043</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paramesh Shamanna, MBBS, MD</last_name>
      <phone>9845010610</phone>
      <email>drparamesh2@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Dr. Ambrish Chandrappa, MBBS, MD</last_name>
      <phone>9845895911</phone>
      <email>ambidrcool@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Government Medical College, Government Medical College Campus,</name>
      <address>
        <city>Calicut</city>
        <state>Kerala</state>
        <zip>673008</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neeraj Manikath, MBBS, DNB</last_name>
      <phone>9447391055</phone>
      <email>nmanikath@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Dr.Chyandni R., MBBS,MD,PHD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Lisie Hospital</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paulose George, MBBS, MD</last_name>
      <phone>9895021667</phone>
      <email>geepee44@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Jabir Abdullakutty, MBBS, DM</last_name>
      <phone>9447011773</phone>
      <email>drjabi@yahoo.co.in</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Indian Institute of Diabetes</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695031</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jabbar P, MBBS, MD</last_name>
      <phone>0471-2559388</phone>
      <email>iidtvm@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Abhilash Nair, MBBS,MD</last_name>
      <phone>9495378383</phone>
      <email>abhimck@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Supe Heart and Diabetes Hospital and Research Centre,</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PRAVIN SUPE, M.D.</last_name>
      <phone>+91-253-2232487</phone>
      <email>pravinsupe@ymail.com</email>
    </contact>
    <contact_backup>
      <last_name>ANUPAMA SUPE, M.B.B.S</last_name>
      <phone>+91-253-2232487</phone>
      <email>pravinsupe@ymail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Medipoint Hospitals Pvt. Ltd</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411007,</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Girish Bhatia, MD</last_name>
      <phone>+917387003636</phone>
      <email>drbhatia.pentagon@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Shailaja G Bhatia, MBBS,MD</last_name>
      <phone>+919527016688</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ashirwad Hospital &amp; Research Centre</name>
      <address>
        <city>Ulhasnagar</city>
        <state>Maharashtra</state>
        <zip>421004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shrikant Deshpande, MBBS, MD</last_name>
      <phone>9822017445</phone>
      <email>writetoshrikant@rediffmail.com</email>
    </contact>
    <contact_backup>
      <last_name>R. M. Mundada, MBBS,MD</last_name>
      <phone>9822676212</phone>
      <email>drrm03@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Dayanand Medical College &amp; Hospital</name>
      <address>
        <city>Ludhiana</city>
        <state>Punjab</state>
        <zip>141001</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Parminder Singh, MBBS, MD, DM</last_name>
      <phone>9814077536</phone>
      <email>pam.endo@yahoo.co.in;</email>
    </contact>
    <contact_backup>
      <last_name>damandeep P Kaur</last_name>
      <phone>9814066999</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>S.R Kalla Memorial Gastro and General Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302001</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Nikhil Parikh, MBBS,MD,DM</last_name>
      <phone>9829054944</phone>
      <email>drnikhilpareek@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Dr. Rajiv Tiwari, MBBS, MD</last_name>
      <phone>+91-141-5112042</phone>
      <email>drrajeevtiwari@rediffmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Diabetes ,Thyroid and Endocrine Centre</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302006</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Surendra K Sharma, MBBS.MD,DM</last_name>
      <phone>9829010233</phone>
      <email>sksharmacr@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sheela Sharma, MBBS.MD</last_name>
      <phone>+91 1412451946</phone>
      <email>sheelasharmacr2016@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Apollo Hospitals, PR No. 3-5-836 to 838, Near Old MLA Quarters,</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harikishan Boorugu, M.B.B.S.M.D.</last_name>
      <phone>9642767757</phone>
      <email>drharikishan@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Dr.Arshad Pujani, M.B.B.S.</last_name>
      <phone>9866081267</phone>
      <email>arpunjani@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>De La Salle Heath Sciences Institute</name>
      <address>
        <city>Dasmariñas</city>
        <state>Cavite</state>
        <zip>4114</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Olivia P Roderos, Endocrlogist</last_name>
      <email>oliveproderos@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Wendy Cudiamat</last_name>
      <email>wcudiamat74@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Angeles University Foundation Medical Center</name>
      <address>
        <city>Angeles City</city>
        <state>Pampanga</state>
        <zip>2009</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Gabriel Jocson, Cardiologist</last_name>
      <email>jocsongabriel@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rose A Barranda, Coordinator</last_name>
      <email>roseann.barranda@yahoo.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>General Luna</city>
        <state>Saint Iloilo City</state>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ygpuara M Lallaine, Int.Med</last_name>
    </contact>
    <contact_backup>
      <last_name>Dr. Efren E Jr, Int.Med</last_name>
      <email>efrenestocejr@yahoo.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Davao Doctors Hospital</name>
      <address>
        <city>Davao City</city>
        <zip>8000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aquitania Grace, Int.Med</last_name>
    </contact>
    <contact_backup>
      <last_name>Emily R Doliente, Int.Med</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>India</country>
    <country>Philippines</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Cardiovascular Risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03254446
org study id: CT/P015/CMR/16/03_01
nct id: NCT03254446
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The phase III trial is designed with an aim of determining the efficacy of Investigational
      Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e.,
      HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel
      group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study
      subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to
      their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26
      weeks.
TRC150094 is an Investigational Product for the treatment of CV risk associated with
      non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by
      increasing the energy expenditure and restoring mitochondrial flexibility which is deranged
      in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful
      benefits in well-established contributors of CV risk i.e., insulin resistance and
      hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP,
      over and above standard of care.

      The phase III trial is designed with an aim of determining the efficacy of TRC150094 in
      concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL
      cholesterol. This study will be a randomized, double blind, parallel group, placebo
      controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will
      receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard
      of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

      Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving
      cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary
      Objectives of the study are,

        1. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension

        2. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in
           subjects with diabetes, dyslipidemia and hypertension

      In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blind
measure: Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c
time frame: 24 Weeks
description: Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms
measure: Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score
time frame: 24 Weeks
description: Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms
measure: Change in MAP
time frame: 24 Weeks
description: Mean change in MAP from baseline to 24 weeks of treatment
measure: Change in non-HDL cholesterol
time frame: 24 Weeks
description: Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment
measure: Change in HbA1c
time frame: 24 Weeks
description: Mean change in HbA1c from baseline to 24 weeks of treatment
measure: Change in weight
time frame: 24 Weeks
description: Mean change in weight from baseline to 24 weeks of treatment
measure: Safety profile of TRC150094
time frame: 50 Weeks
description: The safety profile of TRC150094 beyond 24 weeks of treatment shall also be reported
arm group label: TRC150094 45 mg
arm group type: Experimental
description: TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching Placebo Tablet to be administered orally once a day for 50 weeks
intervention type: Drug
intervention name: TRC150094
description: TRC150094 Tablet 45 mg
arm group label: TRC150094 45 mg
intervention type: Drug
intervention name: Placebo
description: Matching Placebo Tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nikhil Tandon, M.D., PhD
role: Study Chair
affiliation: All India Institute of Medical Sciences, New Delhi
last name: Shohini Ghosh, PhD
phone: +91-79-23969100
phone ext: 574
email: shohinighosh@torrentpharma.com
last name: Girish Deshmukh, PhD
phone: +91-79-23969100
phone ext: 602
email: girishdeshmukh@torrentpharma.com
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: Brazil
country: India
country: Philippines
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Diabetes Mellitus
mesh term: Dyslipidemias
sharing ipd: No