| CTRI Number |
CTRI/2018/10/015899 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| 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 Azelnidipine Tablets 16 mg 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 Azelnidipine Tablets 16 mg Versus Amlodipine Tablets 10 mg in subjects with essential hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/18/01 |
Protocol Number |
| Version 00, Jan 22, 2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Anil Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Gandhi Hospital Secunderabad, Telangana |
| Address |
Department of General Medicine,
Gandhi Hospital, Musheerabad, Secunderabd,
Telangana-500003, India
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
9440523902 |
| Fax |
|
| Email |
anilddrmd@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
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| 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
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| 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 = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Brij Mohan Goyal |
Apex Hospital Pvt. Ltd |
Apex Hospital Pvt. Ltd, SP 4 & 6, MIA,
Malviya Nagar, Jaipur-302017
Jaipur
RAJASTHAN |
9413190570
01412751006
drbrijmohan.goyal@gmail.com |
| Dr Pragati Prakash Bhole |
Department of Medicine, Government Medical College & Hospital Nagpur |
Department of Medicine,
Government Medical College & Hospital,
Medical College Square,
Near Hanuman Nagar, Nagpur-440003, Maharashtra, India.
Nagpur
MAHARASHTRA |
9657726590
pragati.bhole11@gmail.com |
| Dr D Anil Kumar |
Gandhi Hospital |
Department of General Medicine,
Gandhi Hospital, Musheerabad, Secunderabd,
Telangana-500003, India
Hyderabad
ANDHRA PRADESH |
9440523902
anilddrmd@gmail.com |
| Dr Kumar Gouraba Behera |
Institute of Medical Sciences (IMS) and SUM Hospital |
Institute of Medical Sciences (IMS) and SUM Hospital,
S’O’A University,
K8, Kalinga Nagar,
Bhubaneswar-751003, Odisha, India.
Cuttack
ORISSA |
7528948833
dr.kumargaurav137@icloud.com |
| Dr Anupam Mandal |
Institute of Post Graduate Medical Education and Research |
Department of Medicine, 4th Floor,
Ronald Ross Building,
IPGME&R and SSKM Hospital,
244, AJC Bose Road, Kolkata-700020,
West Bengal, India.
Kolkata
WEST BENGAL |
09434120356
mandalanupam75@gmail.com |
| Dr Manish Agarwal |
Medilink Hospital Research Centre |
Medilink Hospital Research Centre,
Basement Medilink Hospital, Nr. Shyamal Cross Road,
132 ft. Ring Road, Satellite, Ahmedabad-380015,
Gujarat, India
Ahmadabad
GUJARAT |
07926760646
07926743051
medilinkhospital@yahoo.com |
| Dr Barama Srihari |
Osmania Medical College & General Hospital |
Dept. of Cardiology,
Osmania Medical College & General Hospital,
Afzalgunj, Hyderabad,
Telangana-500012,
India.
Hyderabad
ANDHRA PRADESH |
7799851491
srihari7399@gmail.com |
| Dr Saurabh Agarwal |
Post Graduate Department of Medicine, GSVM Medical College Kanpur |
Post Graduate Department of Medicine,
GSVM Medical College, Swaroop Nagar,
Kanpur-208002.
Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH |
9415039582
drsaurabhagarwal@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, India
Srikakulam
ANDHRA PRADESH |
9440122790
drgopalraoa@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Centre |
Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oxelbag, Village-Dhargal, Tal-Pemem, Goa-403513.
North Goa
GOA |
919158592177
cromgoa@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Ethics Committee, Institute of Medical Sciences (IMS) and SUM Hospital |
Approved |
| Ethics Committee, IPGME&R Research Oversight Committee |
Approved |
| Institutional Ethics Committee, Apex Hospital Private Limited |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College Nagpur |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Approved |
| Medilink Ethics 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 |
| Comparator Agent |
Amlodipine Tablets 10 mg |
Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day. Thus the subject will receive the drug treatment for period of 12 weeks. |
| Intervention |
Azelnidipine Tablets 16 mg |
Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day. Thus the subject will receive the drug treatment for period of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects of age 18-65 years (both inclusive).
2. Treatment naïve subjects diagnosed with mean sitting SBP of ≥160 to ≤180 mm Hg and mean sitting DBP ≥100 to ≤110 mm Hg (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. Subjects with known hypersensitivity to any of the components of the formulation.
2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of 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. Cardiovascular system:
• Known case of secondary or malignant hypertension.
• 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 and any clinically significant cardiac arrhythmias.
|
|
|
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 Azelnidipine Tablets 16 mg in subjects with essential hypertension |
Change from baseline in mean sitting SBP to the end of study (12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjects with essential hypertension |
Change from baseline in mean sitting DBP at the end of study (12 weeks).
Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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)
|
24/10/2018 |
| 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
|
Yet Not |
|
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 Azelnidipine Tablets 16 mg Versus Amlodipine Tablets 10 mg in
subjects with essential hypertension.
Primary
Objective: To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg in
subjects with essential hypertension.
Secondary
Objective: To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjects
with essential hypertension.
|