CTRI/2019/12/022455 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On:
05/08/2020
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 of Combination of Benidipine plus Telmisartan Tablets for the treatment of subjects with Hypertension.
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 Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets versus Telmisartan Tablets 40 mg and Telmisartan Tablets 80 mg monotherapy in subjects with stage 2 hypertension.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CR/CT/18/004
Protocol Number
Version No. 00, Dated Aug 31, 2018
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr A Gopal Rao
Designation
Associate Professor
Affiliation
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Address
Department of Medicine,
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam-532001
Srikakulam ANDHRA PRADESH 532001 India
Phone
8942279033
Fax
Email
drgopalraoa@gmail.com
Details of Contact Person Scientific Query
Name
Rahul Vij
Designation
AGM - Regulatory Affairs
Affiliation
Synokem Pharmaceuticals Ltd.
Address
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
New Delhi DELHI 110087 India
Phone
9999225948
Fax
Email
dra.domestic@synokempharma.com
Details of Contact Person Public Query
Name
Rahul Vij
Designation
AGM - Regulatory Affairs
Affiliation
Synokem Pharmaceuticals Ltd.
Address
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
New Delhi DELHI 110087 India
Phone
9999225948
Fax
Email
dra.domestic@synokempharma.com
Source of Monetary or Material Support
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India.
Primary Sponsor
Name
Synokem Pharmaceuticals Ltd
Address
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India.
Department of General Medicine,
All India Institute of Medical Sciences,
Sijua, Patrapada,
Dumduma, Bhubaneswar-751019. Khordha ORISSA
9437800568
anupama6799@gmail.com
Dr Surender Deora
All India Institute Of Medical Sciences
Department of Medicine,
All India Institute Of Medical Sciences, Basni Industrial Area, Phase-2, Jodhpur, Rajasthan-342005 Jaipur RAJASTHAN
8003996715
drsdeora@gmail.com
Dr Brij Mohan Goyal
Apex Hospital Pvt. Ltd
Department of Cardiology,
Apex Hospital Pvt. Ltd, SP 4 & 6, MIA, Malviya Nagar, Jaipur-302017
Jaipur Jaipur RAJASTHAN
9413190570
drbrijmohan.goyal@gmail.com
Dr Deepak Gupta
Barala Hospital & Research Center
Department of Medicine,
Barala Hospital & Research Center, Radhaswami Bagh, NH-11, Jaipur Road, Chomu-3037 Jaipur RAJASTHAN
919414047011
dr.deepakgupta11@gmail.com
Dr Krishna Madhukar Giri
Dhadiwal Hospital In Coalition with Shreeji Health Care
Dhadiwal Hospital In Coalition with Shreeji Health Care, Opp. New CBS, Trimbak Road, Nashik-422002. Nashik MAHARASHTRA
9975753763
drkmgiri@gmail.com
Dr Hrishikesh Bora
Down Town Hospital Ltd.
Down Town Hospital Ltd.,
Dispur, G.S. Road,
Guwahati-781006. Kamrup ASSAM
9864044323
hris_11@yahoo.co.in
Dr Manish Gutch
Dr Ram Manohar Lohia Combined Hospital
Department of Medicine, Dr. Ram Manohar Lohia Combined Hospital, Vibhuti Khand, Gomati Nagar, Lucknow-226010 Lucknow UTTAR PRADESH
9453429252
manish07gutch@gmail.com
Dr S Ravindra Kumar
Gandhi Medical College / Hospital
Department of General Medicine, Gandhi Hospital, Musheerabad, Secunderabad-500003 Hyderabad TELANGANA
9848130226
drsudarsi@gmail.com
Dr Prajapati Vipulkumar Bachubhai
GCS Medical College, Hospital and Research Centre
Department of Medicine,
GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad – 380025 Ahmadabad GUJARAT
9909912551
prajapativipul1983@gmail.com
Dr Mukund Anant Deshpande
Government Medical College and Super Specialty Hospital
Department of Cardiology, Government Medical College and Super Specialty Hospital, Medical College Square, Nagpur-440003 Nagpur MAHARASHTRA
9823056562
drmukunddeshpande@gmail.com
Dr Richa Giri
GSVM Medical College
Post Graduate Department of Medicine, GSVM Medical College, Swaroop Nagar Kanpur-208002 Kanpur Nagar UTTAR PRADESH
8400331045
krricha227@gmail.com
Dr Chandan Das
Institute of Medical Sciences & SUM Hospital
Dept. of General Medicine,
Institute of Medical Sciences & SUM Hospital,
Kalinga Nagar,
Ghatikia,
Bhubaneswar-751003 Khordha ORISSA
9937063390
drchandan_das1204@rediffmail.com
Dr Subrata Halder
Institute of Post Graduate Medical Education & Research
Dept. of Medicine, 4th Floor, Ronald Ross Building, IPGME&R and SSKM Hospital 244, AJC Bose Road, Kolkata-700020 Kolkata WEST BENGAL
8584806678
sh.ipgmer@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru (J.L.N) Medical College
Department of Medicine, Jawahar Lal Nehru (J.L.N) Medical College, Kala Bagh, Ajmer-305001. Ajmer RAJASTHAN
Medical College and Hospital, Kolkata,
MCH Building, 4th Floor, 88 College Street, Kolkata-700073. Kolkata WEST BENGAL
9477305539
rbrbhattacharya@gmail.com
Dr P Anand Yadav
Osmania Medical College & General Hospital
Department of Cardiology, Osmania Medical College & General Hospital, Afzalgunj, Hyderabad-500012 Hyderabad TELANGANA
9159860037
anand6pasula@gmail.com
Dr A Gopal Rao
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Department of Medicine, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital Srikakulam-532001, Andhra Pradesh Srikakulam ANDHRA PRADESH
8942279033
drgopalraoa@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Centre
Redkar Hospital and Research Centre,
Mumbai-Goa Highway, Oxelbag, Village-Dhargal,
Pernem-403513. North Goa GOA
FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Intervention
FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Comparator Agent
Telmisartan Tablets 40 mg
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Comparator Agent
Telmisartan Tablets 80 mg
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
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 (both inclusive).
2. Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of ≥160 to ≤180 mmHg and mean seated DBP ≥100 to ≤110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
4. Subjects willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug.
3. 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.
4. Subjects with known case of Secondary or Malignant Hypertension.
5. Subjects with evidence of postural hypotension (defined as drop in more than 20 mg of Hg for systolic blood pressure and morethan 10 mm of Hg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
6. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
7. Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
8. Subjects with known case of Stroke.
9. Subjects with abnormal Renal Function Test (RFT).
10. Subjects with abnormal eGFR (less than 60 mL per min per 1.73 m2).
11. Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
12. Subjects with hyponatremia as per blood biochemistry results at screening.
13. Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening.
14. Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal.
15. Subjects with abnormal Thyroid Function Test (TSH)
16. Subjects with known case of Type 1 Diabetes.
17. Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
18. Subjects with medical history of Oncological Conditions since last 2 years.
19. Subjects with known case of Epileptic seizures.
20. Subjects with clinical history of bipolar disorder i.e. who are taking lithium.
21. Subjects with known case of HIV, Hepatitis B & C.
22. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
23. Females who are not ready to use acceptable contraceptive methods during the course of study.
24. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
25. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
26. Suspected inability or unwillingness to comply with the study procedures.
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
Mean change in seated systolic blood pressure (SeSBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point].
At Baseline, Week 1, Week 2, Week 4, Week 8 and Week 12
Secondary Outcome
Outcome
TimePoints
Mean change in seated diastolic blood pressure (SeDBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last DBP reading at the time of discontinuation will be considered as end point].
At Baseline, Week 1, Week 2, Week 4, Week 8 and Week 12
Mean change in ambulatory blood pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks).
At Baseline and Week 12
The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].
At Week 1, Week 2, Week 4, Week 8 and Week 12
The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.
At Week 1, Week 2, Week 4, Week 8 and Week 12
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "252" Final Enrollment numbers achieved (India)="252"
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 Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets versus Telmisartan Tablets 40 mg and Telmisartan Tablets 80 mg monotherapy in subjects with stage 2 hypertension.
Primary objective:
To evaluate the efficacy of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets in subjects with stage 2 hypertension.
Secondary objective:
To evaluate the safety and tolerability of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets in subjects with stage 2 hypertension.