| CTRI Number |
CTRI/2021/11/037926 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2022 |
| 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 Phase-III clinical study to compare the Efficacy, Safety and Tolerability of FDC of Telmisartan 40mg plus Bisoprolol 5 mg tablets versus FDC of Telmisartan 40mg plus Metoprolol Succinate ER 50 mg tablets in the treatment of Stage 1 and Stage 2 Hypertension |
|
Scientific Title of Study
|
A Randomized, Double Blind, Parallel Group, Multicentric, Phase-III clinical study to compare the Efficacy, Safety and Tolerability of FDC of Telmisartan 40mg plus Bisoprolol 5 mg tablets versus FDC of Telmisartan 40mg plus Metoprolol Succinate ER 50 mg tablets in the treatment of Stage 1 and Stage 2 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 Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of medical services,
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of medical services
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
DGM Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of medical services,
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited 31 Race Course Road Bangalore 560001 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
31 Race Course Road Bangalore 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Micro Labs Limited |
31 Race Course Road Bangalore 560001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurpreet S Wander |
Dayanand Medical College & Hospital, Ludhiana |
Dept of Cardiology, Civil Lines, Tagore Nagar
Ludhiana
PUNJAB |
01614688800
apigswander@gmail.com |
| Dr Vipulkumar Prajapati |
GCS Medical College, Hospital & Research Center |
Dept of medicine, Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge,
Ahmadabad
GUJARAT |
07966048000
prajapativipul1983@gmail.com |
| DrSSVVNarasinga Rao |
Govt Medical College and Govt General Hospital, (Old RIMSGGH) |
Dept of medicine, shantinagar,
Srikakulam
ANDHRA PRADESH |
9912320517
drnarasingaraossvv@yahoo.com |
| Dr Bhim Ram |
Indira Gandhi Institute of Medical Sciences |
Dept of Medicine, Sheikhpura
Patna
BIHAR |
06122297631
bhimdr42197@gmail.com |
| Dr S K Sonkar |
King Georges Medical University |
Dept of medicine, Shah Mina Rd, Chowk,
Lucknow
UTTAR PRADESH |
05222258880
satyendra.sonkar@gmail.com |
| Dr Padmanabh Kamath |
KMC Hospital |
Dept of Cardiology, Dr B R Ambedkar Circle, Mangalore - 575001
Dakshina Kannada
KARNATAKA |
9448107770
kamathcardio@gmail.com |
| Dr R Balamurugan |
Kovai Diabetes Speciality Centre & Hospital |
Dept of medicine, 15, Vivekananada Road, Ram Nagar,
Coimbatore
TAMIL NADU |
04224377732
rbmkdsc@gmail.com |
| Dr L Sreenivasamurthy |
Life Care Hospital and Research Centre |
Dept of medicine, 2748/2152 16th E Cross Road, 8th Main, Dblock , Sahakarnagar
Bangalore
KARNATAKA |
08023631055
drlsm@lcrc.in |
| Dr Debabrata Roy |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
Dept of cardiology, 124, Mukundapur, E.M.Bypass,
Kolkata
WEST BENGAL |
03371222222
debroy67@ymail.com |
| Dr C N Manjunath |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Dept of Cardiology, Bannerghatta Road, Jayanagar 9th Block
Bangalore
KARNATAKA |
08022977395
drcnmanjunath@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee , Dayanand Medical College & Hospital, Ludhiana |
Approved |
| IEC, GCS Medical College, Hosp and Research Centre |
Approved |
| Institute Ethics Committee KMC Hospital Mangalore |
Approved |
| Institute Ethics Committee, NH-Rabindranath Tagore International Institute of Cardiac Sciences |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam |
Approved |
| Institutional Ethics Committee Kovai Diabetes Speciality Centre and Hospital |
Approved |
| Institutional Ethics Committee, IGIMS ,Patna |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
| Life Care Hospital Institutional Review Board Life Care Hospital and Research Centre, Sahakarnagar, Bangalore |
Approved |
| Sri Jayadeva Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Telmisartan 40 mg and Metoprolol Succinate ER 50 mg tablets |
orally once a day |
| Intervention |
FDC of Telmisartan 40 mg and Bisoprolol 5 mg tablets |
orally once a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18-65 years of age of both gender
2. Subject with essential hypertension with seated systolic BP (SeSBP) ≥140 to ≤180 mmHg and having seated diastolic BP (SeDBP) ≥ 90 to ≤ 110 mmHg (Stage 1 and Stage 2 Hypertension, Indian Hypertension Guidelines –IV, 2019).
3. Subjects on monotherapy with either ARB (Telmisartan, Olmesartan, Azilsartan, Losartan) or CCBs (Amlodipine, Benidipine, Cilnidipine, Efonidipine, Azilnidipine) or Bisoprolol or Metoprolol since ≥12 weeks
4. Female subjects of childbearing potential using adequate contraception
5. Willingness to sign written informed consent document
|
|
| ExclusionCriteria |
| Details |
1. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
2. Presence of any clinically relevant disease/disorder (e.g. severe hepatic impairment, chronic renal failure, thromboembolic disorders, recent acute myocardial infarction, history of bronchial asthma, severe COPD etc.)
3. 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.
4. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator
5. Subjects who has evidence of a secondary hypertension.
6. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than first degree or significant first degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
7. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
8. Any significant illness or drugs that could interfere with study parameters
9. Subject with known allergy or hypersensitivity to any of the components of the formulation
10. Any other condition that in opinion of the investigator does not justify patient’s participation in study.
11. Participation in another clinical trial within past 30 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12
• Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
|
• Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12
• Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of subjects achieving Seated Systolic Blood Pressure (SeSBP) less than 140 mmHg from baseline to Week-12
Proportion of subjects achieving Seated Diastolic Blood Pressure (SeDBP) less than 90 mmHg from baseline to Week-12 |
Day 0 , Week 12 |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
Final Enrollment numbers achieved (Total)= "264"
Final Enrollment numbers achieved (India)="264" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2021 |
| Date of Study Completion (India) |
28/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
to be decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized, Double Blind, Parallel Group,
Multicentric, Phase-III clinical study to compare the Efficacy, Safety and
Tolerability of FDC of Telmisartan 40mg + Bisoprolol 5 mg tablets versus FDC of
Telmisartan 40mg + Metoprolol Succinate ER 50 mg tablets in the treatment of
Stage 1 and Stage 2 Hypertension |