| CTRI Number |
CTRI/2019/07/020126 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| 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 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 Azelnidipine Tablets 8 mg / 16 mg versus Amlodipine Tablets 5 mg / 10 mg in subjects with essential hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR/CT/18/003 |
Protocol Number |
| Version No. 3.0; Dated Sep 27, 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 General Medicine, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9440122790 |
| Fax |
|
| Email |
rimsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinav Arora |
| Designation |
Managing Director |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India.
New Delhi
DELHI
110087
India |
| Phone |
9811882440 |
| Fax |
|
| Email |
dra@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhinav Arora |
| Designation |
Managing Director |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India.
New Delhi
DELHI
110087
India |
| Phone |
9811882440 |
| Fax |
|
| Email |
dra@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. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Anil Kumar |
Gandhi Hospital |
Department of General Medicine, Musheerabad, Secunderabd-500003, Telangana, India.
Hyderabad
TELANGANA |
9440523902
anilddrmd@gmail.com |
| Dr Mukund Anant Deshpande |
Government Medical College & Super SpecialityHospital |
Department of Cardiology, Medical College Square, Nagpur-440003, Maharashtra, India.
Nagpur
MAHARASHTRA |
9823056562
drmukunddeshpande@gmail.com |
| Dr Brijesh Kumar |
GSVM Medical College |
Post Graduate Department of Medicine, Swaroop Nagar Kanpur-208002, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH |
9411870108
drbrijeshkumar74@gmail.com |
| Dr Srabani Ghosh |
Institute of Post Graduate Medical Education & Research |
Department of Medicine, 4th Floor, Ronald Ross Building, 244, AJC Bose Road, Kolkata-700020, West Bengal, India.
Kolkata
WEST BENGAL |
9433295970
drsrabanighosh73@gmail.com |
| Dr Barama Srihari |
Osmania Medical College & General Hospital |
Department of Cardiology, Afzalgunj, Hyderabad, Telangana-500012, India.
Hyderabad
TELANGANA |
7799851491
srihari7399@gmail.com |
| Dr A Gopal Rao |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital |
Department of General Medicine, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9440122790
rimsresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, G.S.V.M Medical College |
Submittted/Under Review |
| Ethics Committee, IPGME&R Research Oversight Committee |
Submittted/Under Review |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Osmania Medical College |
Submittted/Under Review |
|
|
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 5 mg / 10 mg |
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks) |
| Intervention |
Azelnidipine Tablets 8 mg / 16 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 1 essential hypertension having mean seated systolic BP (SeSBP) 140 to 159 mmHg and mean seated diastolic BP (SeDBP) 90 to 99 mmHg.
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 >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
|
|
|
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 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 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 |
|
|
Target Sample Size
|
Total Sample Size="236"
Sample Size from India="236"
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)
|
18/07/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NIL |
|
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 8 mg / 16 mg
versus Amlodipine Tablets 5 mg / 10 mg in subjects with essential hypertension.
Primary objective: To evaluate the efficacy of Azelnidipine Tablets 8 mg / 16
mg in subjects with essential hypertension.
Secondary objective: To evaluate the safety and tolerability of Azelnidipine Tablets 8 mg /
16 mg in subjects with essential hypertension.
|