| CTRI Number |
CTRI/2018/10/016182 [Registered on: 29/10/2018] Trial Registered Prospectively |
| Last Modified On: |
20/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study Metoprolol Succinate plus Cilnidipine plus Telmisartan Tablets in patients for treatment of uncontrolled essential hypertension with stable ischemic heart disease |
|
Scientific Title of Study
|
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets versus FDC of Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/17/15 |
Protocol Number |
| Version No. 01, Dated: May 07, 2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Gopal Rao |
| Designation |
Principal Investigator |
| Affiliation |
Rajive Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
| Address |
Rajive Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
919440122790 |
| Fax |
|
| Email |
drgopalraoa@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 Mumbai (Suburban) MAHARASHTRA 400067 India
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| 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 Mumbai (Suburban) MAHARASHTRA 400067 India
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surender Deora |
All India Institute Of Medical Sciences |
All India Institute Of Medical Sciences, Basni Industrial Area, Phase-2, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN |
8003996715
drsdeora@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
01412751006
drbrijmohan.goyal@gmail.com |
| Dr Parmar Kartikeya Ganpatlal |
B. J Medical College & Civil Hospital |
Department of Medicine B.J. Medical College & Civil Hospital, Asarwa, Ahmedabad-380016, Gujarat.
Ahmadabad
GUJARAT |
919924643799
917922685938
drkartik@gmail.com |
| Dr Ajay Bansal |
Bansal Hospital & Research Centre |
Bansal Hospital & Research Centre, 04, Janakpuri-1st, Imli Phatak, Jaipur-302005, Rajasthan, India.
Jaipur
RAJASTHAN |
919950442955
01412592911
dr.ajayb.cr@gmail.com |
| Dr Deepak Gupta |
Barala Hospital & Research Center |
Barala Hospital & Research Center, Radhaswami Bagh, NH-11, Jaipur Road, Chomu-303702
Jaipur
RAJASTHAN |
919414047011
dr.deepakgupta11@gmail.com |
| Dr Richa Giri |
Dr Ram Manohar Lohia Combined Hospital Lucknow |
Department of Medicine, Dr. Ram Manohar Lohia Combined Hospital, Vibhuti Khand, Gomati Nagar, Lucknow-226010.
Lucknow
UTTAR PRADESH |
918400331045
krricha227@gmail.com |
| Dr D Anil Kumar |
Gandhi Hospital |
Department of General Medicine, Gandhi Hospital, Musheerabad, Secunderabad-500003
Hyderabad
ANDHRA PRADESH |
9440523902
anilddrmd@gmail.com |
| Dr Prajapati Vipul Kumar Bachubhai |
GCS Medical College, Hospital and Research Centre |
GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad-380025, Gujarat, India.
Ahmadabad
GUJARAT |
919909912551
917922201915
prajapativipul11983@gmail.com |
| Dr Mukund Anant Deshpande |
Government Medical College and Super Specialty Hospital |
Department of Cardiology Government Medical College and Super Specialty Hospital, Tukdoji Square, Near Hanuman Nagar, Nagpur-440003, Maharashtra, India
Nagpur
MAHARASHTRA |
9823056562
07122746682
drmukunddeshpande@gmail.com |
| Dr Anupam Mandal |
Institute of Post Graduate Medical Education and Research |
Institute of Post Graduate Medical Education and Research, Dept. of Medicine, 4th Floor, Ronald Ross Building, IPGME&R and SSKM Hospital, 244, AJC Bose Road, Kolkata-700020.
Kolkata
WEST BENGAL |
09434120356
mandalanupam75@gmail.com |
| Dr Raju H Badiger |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belgavi, Karnataka-590010
Belgaum
KARNATAKA |
919986447523
rajubadiger@yahoo.com |
| Dr Mahmodullah Razi |
LPS Institute of Cardiology GSVM Medical College Kanpur |
LPS Institute of Cardiology GSVM Medical College Rawatpur, Kanpur-208019
Kanpur Nagar
UTTAR PRADESH |
917408427786
drmmrazi@gmail.com |
| Dr Manish Agarwal |
Medilink Hospital Research Centre |
Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad-380015, Gujarat.
Ahmadabad
GUJARAT |
919825443397
medilinkresearchcentre@yahoo.com |
| Dr Barama Shrihari |
Osmania General Hospital |
Department of Cardiology, Osmania Medical College & General Hospital Afzalgunj, Hydrabad, T.S-500012, India.
Hyderabad
TELANGANA |
917799851491
srihari7399@gmail.com |
| Dr A Gopal Rao |
Rajiv Gandhi Institute of Medical Science & RIMS Govt. General Hospital |
Rajiv Gandhi Institute of Medical Science & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
918942279033
918942279033
drgopalraoa@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Center |
Redkar Hospital and Research Center, Mumbai-Goa Highway, Oshalbag,Village-Dhargal, Tal-Pernem, Goa-403513
North Goa
GOA |
91-9158592177
cromgoa@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Ethics Committee, IPGME&R Research Oversight Committee |
Submittted/Under Review |
| Institutional Ethics Committee (IEC), Barala Hospital & Research Center |
Submittted/Under Review |
| Institutional Ethics Committee (IEC), KLE University, JN Medical College |
Submittted/Under Review |
| Institutional Ethics Committee B. J. Medical College & Civil Hospital |
Approved |
| Institutional Ethics Committee Bansal Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Apex Hospital Private Limited |
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 |
Approved |
| Institutional Ethics Committee, GCS Medical College, Hospital & Research Centre |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Osmania Medical College, Koti |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Approved |
| Institutional Human Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Medilink Ethics Committee |
Approved |
| Redkar Hospital & Research Center Institutional Ethics Committee (RHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets |
Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day for 84 days |
| Intervention |
Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg |
Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day for 84 days |
| Comparator Agent |
Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg |
Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged between 18 and 65 years.
2. Subjects with the history of uncontrolled essential hypertension with stable ischemic heart disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable doses of Metoprolol Succinate ER 25 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
3. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
4. 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 with diagnosed 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. Cardiovascular system, Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias. Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year. Subjects with known case of stroke. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease |
at the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease |
at the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
31/10/2018 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets versus FDC of Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease. Primary Objective: To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease. Secondary Objective: To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease. |