| CTRI Number |
CTRI/2018/12/016625 [Registered on: 12/12/2018] Trial Registered Prospectively |
| Last Modified On: |
29/07/2019 |
| 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 Combination of Efonidipine Hydrochloride Ethanolate 20 mg/20 mg and Metoprolol Succinate ER 25 mg/ 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate ER Tablets 50 mg Monotherapy 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 Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/17/09 |
Protocol Number |
| Dated: Apr 05, 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 |
Rajive Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
| Address |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General
Hospital, Srikakulam-532001.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
919440828299 |
| Fax |
|
| Email |
rimsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02228672111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02228672111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd, Advent 43 AB/44BCD, Charkop Industrial Estate, Kandivali West, Mumbai.
Maharashtra 400067 |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Advent 43 AB / 44BCD, Charkop Industrial Estate, Kandivali West.
Mumbai. Maharashtra 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Bansal |
Bansal Hospital & Research Centre |
4, Janakpuri-I, Janakpuri, Imli Phatak, Tonk Phatak, Jaipur, Rajasthan 302015
Jaipur
RAJASTHAN |
09950442955
01412591110
dr.ajayb.cr@gmail.com |
| Dr Swapnav Borthakur |
Down Town Hospital |
Down Town Hospital,
Dispur, G.S. Road, Guwahati-781006, Assam, India.
Jorhat
ASSAM |
919864038704
swapnav.borthakur@gmail.com |
| Dr D Anil Kumar |
Gandhi Hospital |
Department of General Medicine,
Gandhi Hospital, Musheerabad, Secunderabd-500003
Hyderabad
TELANGANA |
9440523902
anilddrmd@gmail.com |
| Dr Prajapati Vipulkumar Bachubhai |
GCS Medical College, Hospital and Research Center |
Department of Medicine,GCS Medical College, Hospital & Research Center, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025, Gujarat, India
Ahmadabad
GUJARAT |
919909912551
917922201915
prajapativipul1983@gmail.com |
| Dr Brijesh Kumar |
GSVM Medical College |
Post Graduate Department of Medicine, GSVM Medical College, Swaroop Nagar Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
919411870108
drbrijeshkumar74@gmail.com |
| Dr Sudhir 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 |
9204938206
sudh75@gmail.com |
| Dr Srabani Ghosh |
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 |
919433295970
drsrabanighosh73@gmail.com |
| Dr S K Sonkar |
King Georges Medical University |
King Georges Medical University Lucknow-226003.
Lucknow
UTTAR PRADESH |
919307288648
satyendra.sonkar@gmail.com |
| Dr Barama Srihari |
Osmania Medical College & General Hospital |
General Physician,
Dept.of Cardiology
Osmania Medical College & General Hospital
Afzalgunj, Hyderabad, Telangana-500012, India.
Hyderabad
TELANGANA |
917799851491
srihari7399@gmail.com |
| Dr K Sunil Naik |
Rajiv Gandhi Institute of Medical Sciences |
Department of Medicine,
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital,
Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
918942279033
919440828299
rimsresearch@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Center |
Mumbai_Goa highway, Oshalbag, Village-Dhargal, Tal-Pernem, Goa-403513
North Goa
GOA |
9158592177
cromgoa@gmail.com |
| Dr Madhukar Gangaram Gaikwad |
St. George Hospital |
St. Georges Hospital affiliated to Grant Government Medical College & Sir JJ Group
of Hospitals, Mumbai. P DMello Rd, Chhatrapati Shivaji Terminus Area, Behind
GPO, Mumbai, Maharashtra 400001
Mumbai
MAHARASHTRA |
919769998885
drgaikwadmg@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Institutional Ethics Committee Bansal Hospital & Research Centre |
Approved |
| Institutional Ethics Committee GCS Medical College, Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Grant Govt. Medical College and Sir J. J. Group of Hospital |
Approved |
| Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences (IGMS) |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Approved |
| Institutional Ethics Committee, Office of Research Cell, Administrative Block, King George’s Medical University, |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Approved |
| IPGME&R Research Oversight Committee |
Approved |
| Redkar Hospital & Research Center Institutional Ethics Committee (RHIEC) |
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 |
| Intervention |
Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets |
one tablet once a day orally in the morning after breakfast around same time for 12 weeks |
| Intervention |
Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets |
one tablet once a day orally in the morning after breakfast around same time for 12 weeks |
| Comparator Agent |
Efonidipine Hydrochloride Ethanolate Tablets 20 mg |
one tablet once a day orally in the morning after breakfast around same time for 12 weeks |
| Comparator Agent |
Metoprolol Succinate Extended Release Tablets 50 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 more than 160 to less than 180 mmHg and mean DBP more than 100 to less than 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 either of the study medications or any of the ingredients of the formulation.
2. Subjects with known case of Secondary or Malignant Hypertension.
3. Subjects with abnormal Renal Function Test.
4. Subjects with abnormal eGFR 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.
7. Subjects with abnormal Liver Function Tests.
8. Subjects with abnormal Thyroid Function Test.
9. Subjects with known case of Type 1 Diabetes Mellitus will be excluded from the study.
10. 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.
11. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias.
12. Subjects with known case of Stroke.
13. Subject with clinical history of Bronchospastic disorders.
14. Subjects with medical history of Oncological Conditions since last 2 years.
15. Subjects with known case of Epileptic seizures.
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 listed and inability/unwillingness to discontinue them for the entire study period.
20. Suspected inability or unwillingness to comply with the study procedures.
21. Subjects with abnormal Serum potassium.
|
|
|
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 Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension |
Change from baseline in mean sitting SBP to the end of study (12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the tolerability of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension |
Change from baseline in mean sitting DBP to 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="300"
Sample Size from India="300"
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)
|
14/12/2018 |
| 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 Yet |
|
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 Fixed Dose Combination (FDC) of Efonidipine Hydrochloride
Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and
Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended
Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg
and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects
with Stage 2 Hypertension
Primary
Objective
· To evaluate the efficacy
and safety of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride
Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and
Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended
Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg
and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects
with Stage 2 Hypertension.
Secondary
Objective
· To evaluate the
tolerability of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride
Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and
Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended
Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg
and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects
with Stage 2 Hypertension. |