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CTRI Number  CTRI/2019/08/020990 [Registered on: 30/08/2019] Trial Registered Prospectively
Last Modified On: 30/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study of Combination of Metoprolol Succinate plus Chlorthalidone plus Telmisartan Tablets for treatment of Hypertension. 
Scientific Title of Study   A Multicentric, Open Label, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APL/CT/17/12  Protocol Number 
Dated: Mar 01, 2018, Version No. 01  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Barama Shrihari 
Designation  Principal Investigator 
Affiliation  Osmania Medical College & General Hospital 
Address  Dept. of Cardiology, Osmania Medical College & General Hospital, Afzalgunj, Hyderabad, Telangana-500012, India.

Hyderabad
TELANGANA
500012
India 
Phone  7799851491  
Fax    
Email  srihari7399@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh 
Designation  Sr. Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Ltd 
Address  Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate, Kandivli West

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  022229612111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh 
Designation  Sr. Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Ltd 
Address  Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate, Kandivli West

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  022229612111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma Ltd, Advent 43 AB/44BCD, Charkop Industrial Estate, Kandivali West, Mumbai. Maharashtra 400067 
 
Primary Sponsor  
Name  Ajanta Pharma Ltd 
Address  Advent 43 AB / 44BCD, Charkop Industrial Estate, Kandivali West. Mumbai. Maharashtra 400067 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Barama Srihari  Osmania Medical College & General Hospital  General Physician, Dept. of Cardiology Osmania Medical College & General Hospital Afzalgunj, Hyderabad, T.S· 500012, India.
Hyderabad
TELANGANA 		 7799851491

srihari7399@gmail.com 
Dr Brij Mohan Goyal  Apex Hospital Pvt. Ltd  Apex Hospital Pvt. Ltd, SP 4 & 6, MIA, Malviya Nagar, Jaipur-302017
Jaipur
RAJASTHAN 		 9413190570

drbrijmohan.goyal@gmail.com 
Dr Deepak Gupta  Barala Hospital & Research Center  Barala Hospital & Research Center, Radhaswami Bagh, NH-11, Jaipur Road, Chomu-3037
Jaipur
RAJASTHAN 		 919414047011

dr.deepakgupta11@gmail.com 
Dr Hrishikesh Bora  Down Town Hospital  Down Town Hospital, Dispur, G.S. Road, Guwahati· 781006
Jorhat
ASSAM 		 9864044323

hris_11@yahoo.co.in 
Dr Naveen Jamwal  Dr. Ram Manohar Lohia Institute of Medical Sciences  Dr. Ram Manohar Lohia Institute of medical Sciences, Vibhuti Khand, Gomati Nagar, Lucknow-226010
Lucknow
UTTAR PRADESH 		 9415112357

drjamwal@yahoo.com 
Dr D Anil Kumar  Gandhi Hospital  In Patient Block, Department of Medicine, Gandhi Hospital, Musheerabad,Secunderabad, Telangana-500003
Hyderabad
TELANGANA 		 9440523902

anilddrmd@gmail.com 
Dr Prajapati Vipulkumar Bachubhai  GCS Medical College, Hospital and Research Centre  GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad – 380025. Gujarat, India
Ahmadabad
GUJARAT 		 9909912551

prajapativipul1983@gmail.com 
Dr Mukund Anant Deshpande  Government Medical College and Super Specialty Hospital  Department of Cardiology Government Medical College and Super Specialty Hospital, Medical College Square, Nagpur-440003
Nagpur
MAHARASHTRA 		 9823056562

drmukunddeshpande@gmail.com 
Dr Mahmodullah Razi  GSVM Medical College Kanpur  LPS Institute of Cardiology, GSVM Medical College Rawatpur, Kanpur-208019
Kanpur Nagar
UTTAR PRADESH 		 7408427786

drmmrazi@gmail.com 
Dr Subrata Halder  Institute of Post Graduate Medical Education & Research  Dept. of Medicine, 4th Floor, Ronald Ross Building, IPGME&R and SSKM Hospital 244, AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL 		 8584806678

sh.ipgmer@gmail.com 
Dr Sumit Anand  Maharaja Agrasen Superspeciality Hospital  Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidhyadhar Nagar, Jaipur-302039, Rajasthan, India
Jaipur
RAJASTHAN 		 09929082000
01412334609
dr.anandsumit@gmail.com 
Dr Debashish Baidya  Marwari Hospital And Research Centre  Marwari Hospital And Research Centre, S J Road, Athgaon, Guwahati-781008
Jorhat
ASSAM 		 8723085653

drbaidyamdmed@gmail.com 
Dr Sagar Redkar  Redkar Hospital and Research Centre  Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oshalbag, Village Dhargal, Tal-Pernem, Goa-403513
North Goa
GOA 		 9158592177

redkar.research@gmail.com 
Dr K Sunil Naik  RIMS Government General Hospital,  Department of General Medicine, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam- 532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH 		 9440828299
8942279033
rimsresearch@gmail.com 
Dr Indira Pattnaik  Sparsh Hospitals & Critical Care Pvt Ltd  A/407, Saheed Nagar, Bhubaneshwar-75 1007, Odisha.
Khordha
ORISSA 		 9437246066

indirapattanaik@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
Ethics Committee, Down Town Hospital  Submittted/Under Review 
Ethics Committee, G.S.V.M Medical College  Approved 
Ethics Committee, IPGME&R Research Oversight Committee  Submittted/Under Review 
Ethics Committee, Marwari Hospital & Research Centre  Submittted/Under Review 
IEC Maharaja Agrasen Hospital  Approved 
Institution Ethics Committee of Vidarbha Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee (IEC), Barala Hospital & Research Center  Submittted/Under Review 
Institutional Ethics Committee GCS Medical College, Hospital and Research Centre  Submittted/Under Review 
Institutional Ethics Committee Government Medical College & Hospital Nagpur  Submittted/Under Review 
Institutional Ethics Committee, Apex Hospital Private Limited  Submittted/Under Review 
Institutional Ethics Committee, B. J. Medical College & Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital  Submittted/Under Review 
Institutional Ethics Committee, Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Approved 
Institutional Ethics Committee, Sparsh Hospitals and Critical Care (P) Ltd  Approved 
Redkar Hospital Institutional Ethics Committee (RHlEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets  Subject have to take given medication once daily for 24 weeks at around same time. 
Intervention  Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets   Subject have to take given medication once daily for 24 weeks at around same time. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  To be eligible for the study, Subjects must meet the following criteria:

1. Male or female subjects aged between 18 and 65 years (both inclusive).

2. Subjects of stable coronary artery disease (no change in severity of symptoms or nitrate consumption in previous 3 months).

3. Subjects with the history of uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of fixed drug combination therapy of Metoprolol Succinate ER (25 mg / 50 mg) plus Telmisartan 40 mg Tablets for at least 4 weeks.

4. As judged by the Investigator, based on a medical evaluation performed during the screening period. The medical evaluation must include normal or non-clinically significant physical examination, laboratory examination and 12-lead ECG.

5. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

6. Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.
 
 
ExclusionCriteria 
Details  Subjects with any of the following conditions will be excluded from the study:

1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.

2. Subjects diagnosed with Secondary or Malignant Hypertension.

3. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.

4. Renal system:
4.1 Subjects with abnormal Renal Function Test ( Serum Creatinine Normal range, 0.6 to 1.3 mg/dL) and (BUN Normal range , 7 to 20 mg/dL)

4.2 Subjects with abnormal eGFR (less than 60 mL/min/1.73 m2).

4.3 Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.

4.4 Subjects with hyponatremia as per blood biochemistry results at screening (Normal range, 135 to 145 mEq/L).

4.5 Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening (Normal range, 3.5 to 5.5 mEq/L).
5. Hepatic system:

5.1 Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.

6. Endocrine system:

6.1 Subjects with abnormal Thyroid Function Test (TSH) (Normal range is 0.45 to 4.5 mIU/mL).

6.2 Subjects with Type 1 Diabetes Mellitus.

6.3 Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.

7. Cardiovascular system:

7.1 Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias.

7.2 Subjects with known case of Stroke.

8. Other disease conditions
8.1 Subject with clinical history of Bronchospastic disorders.

8.2 Subjects with medical history of Oncological Conditions since last 2 years.

8.3 Subjects with known case of Epileptic seizures.

8.4 Subjects with clinical history of bipolar disorder i.e. who are taking lithium.

9. Trial related conditions

9.1 Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
9.2 Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.

9.3 Suspected inability or unwillingness to comply with the study procedures.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy and safety of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
 		 Mean change in SeDBP between baseline and 24 weeks

Mean change in SeSBP between baseline and 24 weeks.

The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the tolerability of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD).
 		 Mean change in SeDBP from baseline [Time frame: 12, 16, 20 weeks]

Mean change in SeSBP from baseline [Time frame: 12, 16, 20 weeks]

Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) [Time frame: 12, 16, 20, 24 weeks]

Proportion of patients achieving SeSBP less than 140 mmHg (SeSBP responder) [Time frame: 12, 16, 20, 24 weeks]

Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (24 weeks).
 
 
Target Sample Size   Total Sample Size="244"
Sample Size from India="244" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Ajanta pharma conducting A Multicentric, Open Label, Phase-III Clinical Study to Evaluate the Efficacy, Safety (Primary Objective) and Tolerability (Secondary Objective) of Fixed Dose Combination (FDC) of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD) for 24 weeks in 244 subjects.

 
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