FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045464 [Registered on: 13/09/2022] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effects of fixed dose combination of Metoprolol and Telmisartan (Metosartan) in patients with essential hypertension 
Scientific Title of Study   CONTROL – A Phase IV, open-label, multi-centric, non-comparative study to assess the efficacy and tolerability of fixed dose combination (FDC) of metoprolol and telmisartan (Metosartan) in patients with essential hypertension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SP/CVD/Metosartan/PIV-01-2022   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chintan Khandhedia 
Designation  Lead – Clinical Research and RWE 
Affiliation  Sun Pharma Laboratories Limited (SPLL) 
Address  Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai
Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243245231  
Fax    
Email  chintan.khandhedia@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Markandeywar 
Designation  DGM – Medical Affairs 
Affiliation  Sun Pharma Laboratories Limited (SPLL) 
Address  Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai
Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243245230  
Fax    
Email  neeraj.markandeywar@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Amol Prabhudesai 
Designation  Project Manager-Clinical Operations 
Affiliation  Tech Observer Pvt.Ltd 
Address  1391, 34A, Pandit Vishnu Dutt Marg, RC Basti,Block WZ, Nangal Raya, Janakpuri, New Delhi, Delhi
1391, 34A, Pandit Vishnu Dutt Marg, RC Basti,Block WZ, Nangal Raya, Janakpuri, New Delhi, Delhi
New Delhi
DELHI
110046
India 
Phone  01128524382  
Fax    
Email  amol.prabhudesai@tech-oberver.com  
 
Source of Monetary or Material Support  
Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
 
Primary Sponsor  
Name  Sun Pharma Laboratories Limited SPLL 
Address  Sun Pharma Laboratories Limited (SPLL), SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
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 = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabhakar Doraiaj   Ashwin Clinic  AG 25/53, IV Avenue, Anna Nagar, Chennai 600040
Chennai
TAMIL NADU 		 9884012727

prabhud19@gmail.com 
DrUpendra Kaul   Batra Hospital & medical Research centre   Department of Cardiology,2nd Floor,1, Tughlakabad, M.B Road, New delhi-110062
New Delhi
DELHI 		 01129957661

kaul.upendra@gmail.com 
Dr Manoj Chopada   Chopda Medicare and Research Centre Pvt. Ltd, Magnum Heart Institute  Magnum Heart Institute,Reception,Department of Cardiology, 3/5 Patil lane no 1, Laxmi nagar Near K B H Vidyalaya, Canada conner Nashik 422005 Maharashtra India
Nashik
MAHARASHTRA 		 9823021613

drchopdamanoj@gmail.com 
Dr Gaurav Chhaya  Khyati Multispecialty Hospital  S.No235/2,B/S Tata Motor Showroom, Rajpath Club Bodakdev, Ahemadabad, Gujarat 380015
Ahmadabad
GUJARAT 		 9825324056

gaurav.chhaya2010@gmail.com 
Dr Manish Agarwal  Medlink Hospital Research Centre  Medilink Hospital, Near Shyamal Cross Road, 132 ft. Ring Road, Satellite Ahmedabad 380015 Gujarat, India
Ahmadabad
GUJARAT 		 9825443397

Medilinkhospital@yahoo.com 
Dr Selvamani  Meenakshi Mission Hospital and Research Centre  Meenakshi Mission Hospital and Research Centre,Department of Cardiology,OPD 2nd Floor, Lake Area, Melur Road, Madurai- 625107
Madurai
TAMIL NADU 		 9842158868

dr.selvamani2020@gmail.com 
Dr Kamal Sharma  Sanjivini Super speciallity Hospital  Sanjivini Super speciallity Hospital,First Floor,Department of Cardiology, 1, Uday Park Society Nr Sunrise park vastrapur Ahmedabad 380015 India
Ahmadabad
GUJARAT 		 9426020154

kamalcardio@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Asian Education & Research Foundation  Approved 
INSTITUTIONAL ETHICS COMMITTEE BILLROTH HOSPITALS PVT LTD  Approved 
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre  Approved 
Magna-care Ethics Committee Chopda Medicare and Research Centre Pvt. Ltd   Approved 
Medilink ethics committee  Approved 
Sanjivani Hospital Ethics Committee Sanjivani Super Speciality Hospital Pvt.Ltd.  Approved 
Scientific Research and Ethical Review committee Batra Hospital & Medical Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metosartan  Metosartan – FDC tablets of Metoprolol succinate extended release 25mg + Telmisartan 40mg (Metosartan 25) and Metoprolol succinate extended release 50mg + Telmisartan 40mg (Metosartan 50) Route of Administration-Oral Dosage- Once daily after food Treatment Duration - 8 weeks 
Comparator Agent  NA  NA 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Male or female patients aged between 18 and 65 years (both inclusive) willing to provide written informed consent.
• Patients diagnosed with essential hypertension with co-existing stable ischemic heart disease [no change in severity of symptoms or nitrate
consumption in previous 3 months and defined as either stable symptoms (angina or dyspnea), which are thought to be related to chronic arterial disease (CAD), or asymptomatic patients with prior-diagnosed CAD].
• Patients with uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and/or seated systolic BP (SeSBP) 140 to 200 mmHg based on in-clinic blood pressure AND 24-hr average SBP ≥ 130 and/or DBP ≥ 80 mmHg based on ABPM], heart rate of >70 beats/minute and who is on stable dose of antihypertensive monotherapy for at least 4 weeks.
•Patients recommended FDC of Metoprolol succinate extended release + Telmisartan as part of physician’s clinical decision, in line with the prescribing information (PI) of Metosartan.
• Female subjects of childbearing potential must have a negative urine pregnancy test prior to study entry and must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method or usage of intra-uterine device (IUD) will not be considered as an acceptable method. The patient must be willing to practice recommended and acceptable method of contraception to prevent pregnancy from the time of study entry till 2 weeks post the last dose of study medication. 
 
ExclusionCriteria 
Details  • Presence of any clinically relevant known comorbid conditions like hepatic impairment, chronic renal failure, thromboembolic disorders, cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc.
• Any known cardiac disease/disorder like severe bradycardia, heart block greater than first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc. in which either Metoprolol or Telmisartan (individually or in combination) is contraindicated.
• Presence or history of secondary or malignant hypertension.
• Female subjects who are pregnant or lactating or are likely to become pregnant
• Patients receiving other beta blocker therapy (other than Metoprolol) in the last 4 weeks of treatment period prior to entering the study
• Any relevant clinical condition which, in the opinion of the investigator, could interfere with the outcome of the study.
• Patients expected to be non-compliant to the recommended instructions of the treating physician.
• Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blockers, digitalis glycosides, MAO inhibitors, fluoxetine, paroxetine, propafenone, quinidine, ACE inhibitors, clonidine, aliskiren.
• Patients who have participated in any study of an investigational product within last months.
• Subjects with known intolerance, hypersensitivity or any other contraindication to any of Metoprolol or Telmisartan. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the mean 24-hr SBP and DBP from baseline to 8 weeks on ambulatory blood pressure measurement (ABPM).   8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• Responder rates (BP target of 130/80 mm Hg as per 2017 American College of Cardiology [ACC] guidelines for hypertension) based on mean 24-hour ambulatory blood pressure measurement (ABPM).

• Responder rates (BP target of 130/80 mm Hg) based on in-clinic blood pressure measurements.

• Change in mean of SBP and DBP from baseline to 8 weeks for last 6-hr dosing interval (relative to dose time).

• Change in heart rate from baseline to 8 weeks.

• Proportion of patients achieving the target heart rate (Target heart rate is defined as 60 beats/min and 50 beats/min [range 50 – 60 beats/min]) at the end of study period

• Change in short term blood pressure variability measured at each visit

• Change in 24 hr distribution of BP reduction measured at each visit

• Change in evaluation of early morning BP levels – First 6 hours vs last 3 hours BP difference, calculated from the time of application of ABPM device.
 		 8 Weeks 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 4 
Date of First Enrollment (India)   16/09/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This is a prospective, open label, multi-centric, single arm study to assess the efficacy and tolerability of fixed dose combination (FDC) of metoprolol and telmisartan (Metosartan) in patients with essential hypertension 
Close