| CTRI Number |
CTRI/2022/11/047055 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety and Tolerability in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD).
|
|
Scientific Title of Study
|
A Multicentric, Randomized, Double Blind, Double Dummy, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Telmisartan 40 mg tablets, versus Co administration of Metoprolol succinate 50 mg and Telmisartan 80 mg tablets in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD).
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/22/05 V01 Jun 30, 2022 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishal Shah |
| Designation |
Principal Investigator |
| Affiliation |
Lifeline Multispeciality Hospital |
| Address |
Lifeline Multispeciality Hospital Vishal Complex S V Rd Opposite N L HighSchool Malad West Mumbai Maharashtra
Mumbai
MAHARASHTRA
400095
India |
| Phone |
9833803296 |
| Fax |
|
| Email |
vshah8962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director Mediclin Clinical Research |
| Affiliation |
Mediclin Clinical Research |
| Address |
4th Floor Ambika Industry
Opp Thakur Mall Penkar Pada
Mira Road EastThane 401 107
Maharashtra
Thane
MAHARASHTRA
401 107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director Mediclin Clinical Research |
| Affiliation |
Mediclin Clinical Research |
| Address |
4th Floor Ambika Industry
Opp Thakur Mall Penkar Pada
Mira Road EastThane 401 107
Maharashtra
Thane
MAHARASHTRA
401 107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd
Plot No. 43, AB & 44BCD,
Govt. Industrial Estate, Charkop, Kandiwali (W), Mumbai 400067.
|
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Limited |
| Address |
Plot No 43 AB and 44 BCD
Govt Industrial Estate Charkop
Kandivali West
Mumbai 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kuntal Shah |
Aartham Multi Super Speciality Hospital, Ahmedabad |
OPD room,First floor,Aartham Multi Super Speciality Hospital, Basement-2 Opp. Polytechnic College, Near Panjarapole cross road, Ambawadi, Ahmedabad.380006
Ahmadabad
GUJARAT |
8980075065
kuntalshah64@gmail.com |
| Dr Sunil Naik |
Government Medical College and Govt General Hospital, Srikakulam |
Department of medicine,Government Medical College and Govt. General Hospital, Srikakulam- 532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaik37@gmail.com |
| Dr Mahendra Pal Singh |
GSVM Medical College, Kanpur |
GSVM Medical College Kanpur 208002 UP India
Kanpur Nagar
UTTAR PRADESH |
8765379671
drmahendrapals303@gmail.com |
| Dr Asit Das |
IPGME and R |
IPGME and R SSKM Hospital 244 AJC Bose Road Kolkata 70002 West Bengal India
Kolkata
WEST BENGAL |
9325766933
drasitdas308@gmail.com |
| Dr Sanjeev Maheshwari |
Jawahar Lal Nehru Medical College Ajmer |
Jawahar Lal Nehru Medical College Kala Bagh Ajmer 305001 Rajasthan
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Amit Kumar |
KHIMS Hospital, Kanpur |
KHIMS Hospital, 16/111, Mall Road Kanpur-208001
Kanpur Nagar
UTTAR PRADESH |
9828321416
dramitkumar1938@gmail.com |
| Dr Sundara Raju |
King George Hospital, Vishakapatnam |
King George Hospital,
KGH Down Rd, Opp KGH OP Gate, Maharani Peta, Visakhapatnam, Andhra Pradesh 531011
Visakhapatnam
ANDHRA PRADESH |
9573606609
drsundararaju23@gmail.com |
| Dr Vaishal Shah |
Lifeline Multispeciality Hospital, Mumbai |
OPD Room,Ground floor, Lifeline Multispeciality Hospital, Medicine Department, ground floorVishal Complex, S. V. Rd, Opposite N L High School, Malad West, Mumbai, Maharashtra 400095
Mumbai
MAHARASHTRA |
9833803296
vshah8962@gmail.com |
| Dr Raja Battacharya |
Medical college and hospital, Kolkata |
Medical college and hospital, Kolkata 88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL |
8013434158
drrajabhattacharya106@gmail.com |
| Dr Jitendra Shukla |
Motilal Nehru Medical College, Allahabad |
Motilal Nehru Medical College Civil Lines George Town Allahabad UP
Allahabad
UTTAR PRADESH |
7007582452
drjitendrashukla22@gmail.com |
| Dr Maulita Kapadia |
SMVS Swaminarayan Hospital, Gandhinagar |
OPD Room,Ground floor,SMVS Swaminarayan Hospital, Gandhinagar-Ahmedabad road, Besideswaminarayan Dham, Urjanagar l, Randesan, Gandhinagar, Gujarat 382007
Dham Urjanagar l
Randesan
Gandhinagar Gujarat
382007
Gandhinagar
GUJARAT |
7016057684
drmaulitakapadia088@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Aartham Ethics Committee, Ambawadi, Ahmedabad |
Approved |
| Ethics committee brij medical centre, kanpur nagar, UP |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee for Human Research, Medical college and hospital, Kolkata |
Approved |
| Institutional Ethics Committee MNL Medical College |
Approved |
| Institutional Ethics Committee, Aatrnan Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee, Government Medical College, Srikakulam |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam, Andhra Pradesh |
Approved |
| IPGMEandR Research Oversight Committee |
Approved |
| Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer |
Approved |
| Shah Lifeline Multispeciality and heart institute ethics committee, |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Co-administration of Metoprolol succinate 50 mg and Telmisartan 80 mg tablets |
Two tablets once a day orally with or without food around same time everyday for 12 weeks |
| Intervention |
FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Telmisartan 40 mg tablets |
Two tablets once a day orally with or without food around same time everyday for 12 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged between 18 and 75 years.
2. Subjects of stable coronary artery disease.
3. Subjects with the history of uncontrolled essential hypertension with stable coronary artery disease [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 Metoprolol succinate ER 50 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
5. 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 |
1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Subjects with EF less than 40% as per Simpson’s method on 2D Echo.
3. Subjects diagnosed with Secondary or Malignant Hypertension.
4. Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
5. Renal system:
Subjects with eGFR more than 60 mL per min per 1.73m2
Subjects with abnormal lab values of Na, K, Mg and Uric acid. normal range: Na
Equal to135 to 145 mEq per L, K equal to 3.5 to 5.0 mmol per L, Mg equal to 7 to 12 mg per dL and Uric acid 3.5 to 7.2 mg per dL
6. Hepatic system:
Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
7. Endocrine system:
Subjects with abnormal Thyroid Function Test, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus with HbA1c value greater than 8%.
8. Cardiovascular system:
Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) less than one year or coronary artery bypass graft (CABG) surgery less than one year, sinus node dysfunction and any clinically significant cardiac arrhythmias.
Subjects with known case of Stroke.
9. Other disease conditions
Subject with clinical history of COPD, Bronchial Asthma and Peripheral Vascular disease.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Mean change in SeSBP between baseline and 12 weeks.
The assessment of safety of subjects, comparison of incidence of treatment emergent adverse event (TEAE).
|
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in SeDBP from baseline Time frame: 4, 8 and 12 weeks.
Mean change in SeSBP from baseline Time frame: 4, 8 and 12 weeks.
Proportion of patients achieving SeSBP 140 mmHg (SeSBP responder) Time frame: 4, 8 and 12 weeks.
Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) Time frame 4, 8 and 12 weeks.
Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks).
The assessment of safety and tolerability of Investigational Product will be based on incidence of AEs and SAEs and changes in laboratory values
|
4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
08/11/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
A Multicentric, Randomized, Double Blind, Double Dummy, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg + Telmisartan 40 mg tablets, versus Co-administration of Metoprolol succinate 50 mg and Telmisartan 80 mg tablets in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD) Trial of 84 days with two arms |