| CTRI Number |
CTRI/2023/07/055818 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy and safety of FDC of Azelnidipine and Telmisartan as
compared to FDC of Amlodipine and Telmisartan in Indian Essential Hypertensive Patients |
|
Scientific Title of Study
|
A Prospective, Randomized, Open label, Investigator Initiated academic clinical trial to evaluate the
efficacy and safety of FDC of Azelnidipine and Telmisartan as compared to FDC of Amlodipine and
Telmisartan in Indian Essential Hypertensive Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CE/23/07 Version 00 Dated 29/5/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Ashok Bafna |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Bafna Super speciality Clinic & Star Hospital |
| Address |
Clinical Research Room, Ground Floor, Dr. Bafna Super speciality Clinic & Star Hospital, Rukmini Nagar, E
ward near LIC Ground, Kolhapur 416001.
Kolhapur
Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9145683747 |
| Fax |
|
| Email |
drbafnaakshay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Medical Director |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, SoBo Centre, South Bopal, Ahmedabad.
Ahmadabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Medical Director |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, SoBo Centre, South Bopal, Ahmedabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Dr. Bafna Super speciality Clinic & Star Hospital, Rukmini Nagar, E ward near LIC Ground,
Kolhapur 416001. |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Ashok Bafna |
| Address |
Dr. Bafna Super speciality Clinic & Star Hospital, Rukmini Nagar, E
ward near LIC Ground, Kolhapur 416001. |
| Type of Sponsor |
Other [Self (Principal Investigator)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Ashok Bafna |
Dr. Bafna Super speciality Clinic & Star Hospital |
Clinical Research Room, Ground Floor, Dr. Bafna Super speciality Clinic & Star Hospital, Rukmini Nagar, E
ward near LIC Ground, Kolhapur 416001.
Kolhapur
MAHARASHTRA |
9145683747
drbafnaakshay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Om-Sai Onco Institutional Ethics Committee |
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 |
FDC of Amlodipine 5mg and
Telmisartan 40 mg |
Once daily For 12 weeks |
| Intervention |
FDC of Azelnidipine 16mg and
Telmisartan 40mg |
Once daily For 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
I. Patients of either sex aged between 18 to 75years (both
inclusive)
II. Treatment Naïve hypertensive patients with stage
II hypertension or patients who are not controlled on Telmisartan monotherapy (40 mg) with Stage I or II hypertension
III. Patients willing to provide written informed consent and comply with
the protocol requirements
IV. Subjects having no abnormalities in general physical examination |
|
| ExclusionCriteria |
| Details |
1. Patients with severe hypertension (defined as a DBP ?120 mmHg
or SBP ?180 mmHg)
2. Patients with suspected secondary hypertension, heart failure &
diagnosed cardiovascular diseases, new cerebrovascular diseases,
3. Patients using any other concomitant medications known to affect
BP or medication prohibited as per protocol.
4. Known hypersensitivity or allergy to calcium channel blockers and
angiotensin receptor blockers
5. Patients with the history of Bilateral renal artery stenosis, renal
artery stenosis
in a solitary kidney, patient post–renal transplant or with only one
functioning
kidney
6. Patients with history of any other clinically significant uncontrolled
systemic
diseases such as pulmonary, renal, neurological, psychiatric,
gastrointestinal,
metabolic, endocrine (uncontrolled diabetes mellitus), immunological
or
hematological disorders or malignancy
7. Pregnant or Lactating females; or female patients of childbearing
potential
unwilling to use effective contraception
8. Those who smoke >1 pack of cigarettes per day
9. Patients with continuing history of alcohol and/or drug abuse
10. Participation in another clinical trial within 3 months prior to
screening
11. Any other reason for which the investigator feels that the patient
should not
participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in seated office blood pressure (SBP &
DBP) from baseline to end of 12 weeks in the
two groups |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
For Efficacy; Propotion of patients achieving
normal blood pressure (SBP120 and
DBP80 mmHg) at end of 4 & 12 weeks.
Change in pulse rate from baseline to end of 4 &
12 weeks in two groups.
Change in UACR from baseline to end of 12
weeks in two group. |
From Baseline(week 0) to end of 4 week & 12
week |
For Safety numbers of Adverse events & Serious
adverse events reported during the study. |
From 0 to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Prospective, Randomized, Open label, Investigator Initiated academic clinical trial to evaluate the efficacy and safety of FDC of Azelnidipine (16 mg)and Telmisartan (40 mg) as compared to FDC of Amlodipine (5 mg) and Telmisartan (40 mg) in Indian Essential Hypertensive Patients daily for 12 weeks to evaluate the safety and efficacy between two groups. The primary endpoint of the study is to evaluate the change in seated office blood pressure from baseline (Week 0) to end of 12 weeks in two groups. The secondary endpoints of the study are proportion of patients achieving the normal blood pressure (SBP<120 and DBP<80 mmHg) at end of week 4 & 12, Change in pulse rate from baseline to end of 4 & 12 weeks and change in UACR from baseline to end of 12 weeks in two groups. For safety number of Adverse events and serious adverse events reported during the study. |