| CTRI Number |
CTRI/2022/09/046074 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2023 |
| 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 & Tolerability |
|
Scientific Title of Study
|
A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety & Tolerability of FDC of Metoprolol succinate 50&50 mg plus Amlodipine 5&5 mg plus Chlorthalidone 6.25&12.5 mg Tablets versus Coadministration of Metoprolol succinate 50 mg and Amlodipine 10 mg Tablets for patients with Uncontrolled Essential Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 High School 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 East Thane 401 107
Maharashtra
Thane
MAHARASHTRA
401107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclin.cr |
|
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 East Thane 401 107
Maharashtra
Thane
MAHARASHTRA
401107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclin.cr |
|
|
Source of Monetary or Material Support
|
|
|
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 |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kuntal Shah |
Aartham Multi Super Speciality Hospital |
OPD room, first floor, Basement 2 Opp Polytechnic College Near Panjarapole cross road Ambawadi Ahmedabad 380006
Ahmadabad
GUJARAT |
8980075065
kuntalshah64@gmail.com |
| Dr Ashish Jha |
Dr.Ram Manohar Lohia Institute of Medical Sciences |
Dept of Cardiology, Room No 315, Third floor, OPD building, Mandi Parishad Rd Vibhuti Khand Gomti Nagar Lucknow Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
8176007384
drashishjha209@gmail.com |
| Dr Sunil Naik |
Government Medical College and Govt General Hospital |
Dept of Medicine, Srikakulam 532001 Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaik37@gmail.com |
| Dr Mahendra Pal Singh |
GSVM Medical College |
Department of Medicine, Ward No 15, GSVM Medical College Kanpur 208002 UP India
Kanpur Dehat
UTTAR PRADESH |
8765379671
drmahendrapals303@gmail.com |
| Dr Asit Das |
IPGME & R SSKM Hospital |
Cardiology Block, Room No 5, 244 AJC Bose Road Kolkata 700020 West Bengal India
Kolkata
WEST BENGAL |
9325766933
drasitdas308@gmail.com |
| Dr Sanjeev Maheshwari |
Jawahar Lal Nehru Medical College |
Ground floor,Department of medicine, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001 Rajasthan
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Sanjeev Maheshwari |
Jawahar Lal Nehru Medical College |
Ground floor,Department of medicine, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001 Rajasthan
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Amit Kumar |
KHIMS Hospital |
OPD room, Ground Floor, 16 111 Mall Road Kanpur 208001
Kanpur Dehat
UTTAR PRADESH |
9828321416
dramitkumar1983@gmail.com |
| Dr Sundra Raju |
King George Hospital |
Dept of General Medicine, 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 |
OPD room, V1st floor, ishal Complex S V Rd Opposite N L High School Malad West Mumbai Maharashtra 400095
Mumbai
MAHARASHTRA |
9833803296
vshah8962@gmail.com |
| Dr Vaishal Shah |
Lifeline Multispeciality Hospital |
Vishal 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 |
MCI Main building, 4 th floor, Dept of Medicine, 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 |
OPD room, Department of General Medicine, Civil Lines George Town Allahabad UP
Allahabad
UTTAR PRADESH |
7007582452
drjitendrashukla22@gmail.com |
| Dr Maulita Kapadia |
SMVS Swaminarayan Hospital |
OPD room, Ground floor, Gandhinagar Ahmedabad road Besideswaminarayan Dham Urjanagar l Randesan Gandhinagar Gujarat 382007
Gandhinagar
GUJARAT |
7016057684
drmaulitakapadia088@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Aartham Ethics Committee |
Approved |
| Ethics Committe Brij Medical Center |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee for Human Research, Medical college and hospital, |
Approved |
| Institutional Ethics Committee MNL Medical College |
Approved |
| Institutional Ethics Committee, Dr.Ram Manohar Lohia Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College and Govt. General Hospital |
Approved |
| Institutional Ethics Committee, JLN Medical College |
Approved |
| Institutional Ethics Committee, King George Hospital, |
Approved |
| IPGMEandR Research Oversight Committee |
Approved |
| Shah Lifeline Hospital And Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I159||Secondary hypertension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A
FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Chlorthalidone 6.25 mg Tablets and Placebo
Arm B:
FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Chlorthalidone 12.5 mg Tablets and Placebo
|
Two tablets once daily every morning after breakfast around same time every day for 12 weeks |
| Comparator Agent |
Co-administration of Metoprolol succinate 50 mg and Amlodipine 10 mg Tablets |
Two tablets once daily every morning after breakfast around same time every day 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 (both inclusive).
2. Subjects those who are uncontrolled on FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg.
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 two antihypertensive medications in recommended dose for atleast 4 weeks.
4. As judged by the Investigator, based on a clinical evaluation performed during the screening period.
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 |
Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
Subjects with EF <40% as per Simpson’s method on 2D Echo.
Subjects diagnosed with Secondary or Malignant Hypertension.
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
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)
|
Mean change in SeSBP between baseline and 12 weeks.
The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)
|
|
|
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 90 mmHg (SeDBP responder) [Time frame: 4, 8 and 12 weeks].
Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from as compared to baseline to the end of study (12 weeks).
The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and changes in laboratory values.
|
Baseline 4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
10/10/2022 |
| 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
|
|
Brief Summary
|
A Multicentric,
Randomized, Double Blind, Double Dummy, Parallel Group, Comparative, Phase III
Clinical Study to Evaluate the Efficacy, Safety & Tolerability of FDC of
Metoprolol succinate 50/50 mg + Amlodipine 5/5 mg + Chlorthalidone 6.25/12.5 mg
Tablets versus Co-administration of Metoprolol succinate 50 mg and Amlodipine
10 mg Tablets for patients with Uncontrolled Essential Hypertension. Trial of 84 days with two arms |