CTRI/2018/12/016607 [Registered on: 11/12/2018] Trial Registered Prospectively
Last Modified On:
25/01/2020
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 Study of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Telmisartan Tablets 40 mg as a single drug in a patient for the treatment of 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 Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Telmisartan Tablets 40 mg monotherapy in Subjects with Stage 2 Hypertension.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
APL/CT/17/08
Protocol Number
Date: Mar 01, 2018. Version No. 01
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr K Sunil Naik
Designation
Principal Investigator
Affiliation
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
Address
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Bansal Hospital & Research Centre,
04, Janakpuri 1st Imli Phatak, Jaipur-302005. Rajasthan
Jaipur RAJASTHAN
09950442955
dr.ajayb.cr@gmail.com
Dr Deepak Gupta
Barala Hospital & Research Center
Barala Hospital & Research Center,
Radhaswami Bagh, NH-l1, Jaipur Road,
Chomu-303702 Jaipur RAJASTHAN
9414047011
dr.deepakgupta11@gmail.com
Dr Swapnav Borthakur
Down Town Hospital Ltd
Down Town Hospital, Dispur, G S Road,Guwahati-78l006 Jorhat ASSAM
91-9864038704
swapnav.borthakur@gmail.com
Dr Manish Gutch
Dr. Ram Manohar Lohia Institute of medical Sciences
Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti
Khand. Gomti Nagar. Lucknow-226010 Lucknow UTTAR PRADESH
9453429252
manish07gutch@gmail.com
Dr D Anil Kumar
Gandhi Hospital
In Patient Block, Department of Medicine, Gandhi Hospital, Musheerabad,
Secunderabad, Telangana-500003. Hyderabad TELANGANA
9440523902
anilddrmd@gmail.com
Dr Prajapati Vipulkumar Bachullhai
GCS Medical College, Hospital and Research Centre
GCS Medical College. Hospital and Research Centre,
Opp. DRM Office, Nt. Chamunda Bridge,
Namda Road, Ahmedabad-380025, Gujarat India. Ahmadabad GUJARAT
Government Medical College and Super Specialty Hospital Nagpur
Department of Cardiology
Government Medical College and Super Specialty Hospital,
Medical College Square, Nagpur-440003 Nagpur MAHARASHTRA
9823056562
drmukunddeshpande@gmail.com
Dr Mahmodullah Razi
GSVM Medical College Kanpur
LPS Institute of Cardiology, GSVM Medical College, Rawatpur, Kanpur-208019 Kanpur Nagar UTTAR PRADESH
7408427786
dnnmrazi@gmail.com
Dr Madhukar Gangaram Gaikwad
GT Hospital, Grant Govt. Medical College & Sir JJ Group of Hospitals
GT Hospital, Grant Government Medical College & Sir JJ Group
of Hospitals, LT Road, Mumbai. Mumbai (Suburban) MAHARASHTRA
919769998885
drgaikwadmg@gmail.com
Dr Praveen Kumar
Indira Gandhi Institute of Medical Sciences Patna (IGMS)
Department of General Medicine, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-800014, Bihar, India. Patna BIHAR
918051459087
praveen_Kumar_23@yahoo.co.in
Dr Prof Dhurjati Prasad Sinha
Institute of Post Graduate Medical Education & Research
IPGME & R, SSKM Hospital,
244, Acharya Jagadish Chandra Bose Road, Kolkata, West Bengal, India- 700020 Kolkata WEST BENGAL
09433018443
drdpsinha@gmail.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
918584806678
sh.ipgmer@gmail.com
Dr Srabani Ghosh
IPGMER
Dept. of Medicine,IPGMER
4th Floor,
Ronald Ross Building,
244, AJC Bose Road, Kolkata-700020.
Kolkata WEST BENGAL
919433295970
drsrabanighosh73@gmail.com
Dr S Narasinga Rao
King George Hospital
Assistant Professor, Department of Medicine, Rajendra Prasad Ward, King George Hospital,Maharanipeta, Visakhapatnam-530002 Visakhapatnam ANDHRA PRADESH
919848136704 918912782211 snrnaveen007@gmail.com
Dr Raju Badiger
KLES Dr. Prabhakar Kore Hospital and MRC
KLES Dr. Prabhakar Kore Hospital and MRC, Nehru nagar, Belagavi, Karnataka
590010 Belgaum KARNATAKA
9986447523
rajubadiger@yahoo.com
Dr Sunil Prem Chand Massand
Maharaja Agrasen Hospital
Maharaja Agrasen Hospital
West Punjabi Bagh, New Delhi-110Q26 New Delhi DELHI
01140777666
info@mahdelhi.org
Dr Debashish Baidya
Marwari Hospital And Research Centre
Marwari Hospital And Research Centre,
S J Road, Athgaon, Guwahati-781008 Jorhat ASSAM
91-8723085653
drbaidyamdmed@gmail.com
Dr Manoj Kumar Srivastava
Om Research Center, Om Surgical Center & Maternity Home
Om Research Center, Om Surgical Center & Maternity Home, SA-I7/3, P-4, Sri
Krishna Nagar, Paharia, Ghazipur Road, Varanasi-221007, Uttar Pradesh, India. Varanasi UTTAR PRADESH
General Physician,
Dept.of Cardiology
Osmania Medical College & General Hospital
Afzalgunj, Hyderabad, T.S.500012, India. Hyderabad TELANGANA
7799851491
srihari7399@gmail.com
Dr K Sunil Naik
Rajiv Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital
Department of Medicine,
Rajiv Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital,
Srikakulam-53200 1, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
8942279033
rimsresearch@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Center
Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oxelbag, Village-Dhargal, Tal-Pemem, Goa-403513. North Goa GOA
9158592177
cromgoa@gmail.com
Dr Sunil Kumar Mahavar
SMS Medical College & Hospital
SMS Medical College & Attached Hospitals JLN Marg Jaipur-302004 Jaipur RAJASTHAN
One tablet once a day orally in the morning after breakfast around same time for 12 weeks
Comparator Agent
Telmisartan Tablets 40 mg
One tablet once a day orally in the morning after breakfast around same time for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subjects meeting all of the following criteria will be recruited for the trial:
1. Male or Female subjects between 18 to 65 years of age (Both Inclusive).
2. Treatment-Naïve subjects who are suffering from Stage 2 Hypertension.
3. Subjects diagnosed with mean SBP of ≥160 to ≤180 mmHg and mean 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).
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
ExclusionCriteria
Details
Subjects will be excluded if ANY of the following conditions apply:
1. Suspected hypersensitivity to any of the ingredients of study medication.
2. Subjects with known case of Secondary or Malignant Hypertension.
3. Subjects with abnormal Renal Function Test.
4. Subjects with abnormal eGFR less than 60 mL/min/1.73 m2 will be excluded from the study.
5. 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.
6. Subjects with hyponatremia as per blood biochemistry results at screening.
7. Subjects with Serum potassium more than 5.5 mEq/L or less than 3.5 mEq/L at baseline.
8. Subjects with abnormal Liver Function Tests.
9. Subjects with abnormal Thyroid Function Test.
10. Subjects with known case of Type 1 Diabetes will be excluded from the study.
11. Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study.
12. Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias will be excluded from the study.
13. Subjects with known case of Stroke will be excluded from the study.
14. Subjects diagnosed or suffering from any Oncological Conditions since last 2 years will be excluded from the study.
15. Subjects with known case of Epileptic seizures will be excluded from the study.
16. Subjects with clinical history of bipolar disorder i.e. who are taking lithium.
17. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
18. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
19. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
20. 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
To evaluate the efficacy and safety of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets in Subjects with Stage 2 Hypertension
Change from baseline in mean sitting SBP at the end of study (12 weeks).
Secondary Outcome
Outcome
TimePoints
To evaluate the tolerability of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets in Subjects with Stage 2 Hypertension.
Change from baseline in mean sitting DBP at the end of study (12 weeks).
Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) from baseline to the end of study (12 weeks).
Target Sample Size
Total Sample Size="249" Sample Size from India="249" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="244"
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 Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg
Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and
Telmisartan Tablets 40 mg monotherapy in Subjects with Stage 2 Hypertension.â€
Primary
Objective
·To evaluate the
efficacy and safety of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan
40 mg Tablets in Subjects with Stage 2 Hypertension.
Secondary
Objective
·To evaluate the
tolerability of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg
Tablets in Subjects with Stage 2 Hypertension.