| CTRI Number |
CTRI/2019/01/017089 [Registered on: 15/01/2019] Trial Registered Prospectively |
| Last Modified On: |
04/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non Interventional Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to check safety and effectiveness of cilnidipine, metoprolol succinate and chlorthalidone in Indian hypertensive patients. |
|
Scientific Title of Study
|
A prospective, observational, Multicenter study to evAluate safety and effIcacy of cilniDipine, mEtoprolol succinate and chlorthalidoNe in high risk hypertensive patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 18-AHPL-007 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Gajjar |
| Designation |
Manager- Medical Service |
| Affiliation |
Aprica Healthcare Pvt Ltd, |
| Address |
A-4, 4th Floor, Safal Profitaire, Off. S.G. Highway,
Corporate road
Ahmadabad
GUJARAT
380015
India |
| Phone |
7573953504 |
| Fax |
|
| Email |
dramit@aprican.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Gajjar |
| Designation |
Manager- Medical Service |
| Affiliation |
Aprica Healthcare Pvt Ltd, |
| Address |
A-4, 4th Floor, Safal Profitaire, Off. S.G. Highway,
Corporate road
Ahmadabad
GUJARAT
380015
India |
| Phone |
7573953504 |
| Fax |
|
| Email |
dramit@aprican.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Gajjar |
| Designation |
Manager- Medical Service |
| Affiliation |
Aprica Healthcare Pvt Ltd, |
| Address |
A-4, 4th Floor, Safal Profitaire, Off. S.G. Highway,
Corporate road
Ahmadabad
GUJARAT
380015
India |
| Phone |
7573953504 |
| Fax |
|
| Email |
dramit@aprican.com |
|
|
Source of Monetary or Material Support
|
| Aprica Healthcare Pvt Ltd
A-4, 4th Floor, Safal Profitaire, Off. S.G. Highway, Corporate road
Ahmadabad
GUJARAT
380015
India |
|
|
Primary Sponsor
|
| Name |
Aprica Healthcare Pvt Ltd |
| Address |
A-4, 4th Floor, Safal Profitaire, Off. S.G. Highway,
Corporate road |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A P Singh |
A. P. Hospital |
Room no 1, Cardiology Department,
Ajit Nagar Extn, Chamrang Road, Near
Water Tank, Amritsar
Amritsar
PUNJAB |
9814502340
ap.hosp@yahoo.com |
| Dr Avais Pathan |
Dr Avais Pathan |
Room no- 6 B, Cardiology Department,
Court Roayal, Christ Church Lane, Clare Road,
Byculla, Mumbai-08
Mumbai
MAHARASHTRA |
9820278865
dr.pathan@gmail.com |
| Dr Jignesh Prajapati |
Dr Jignesh Prajapati |
Room no 1, Cardiology Department,
4th & 5ft Floor Sparsh Complex,
Nr.IOC Petrol Pump,
Opp.Gate No.4 Civil Hospital, Asharva, Ahmedabad- 380016
Ahmadabad
GUJARAT |
9979887969
dr.jignesh.a.prajapati@gmail.com |
| Dr Sandarbh Patel |
Dr Sandarbh Patel |
Cardiology Department,
Room no- 602, Merlin Pentagon, Opp. Badshah Dairy, Nr Mahalaxmi Panch Rasta,
Paldi
Ahmadabad
GUJARAT |
9909031385
drsandarbh.cardio@gmail.com |
| Dr Kaizar Dohadwala |
Kaizar Medical Nursing home |
Room no-1, Cardiology Department,
Opp. Darpan Cinema,
Station road, Dahod- 389151
Gujarat
Dohad
GUJARAT |
9426504114
dr.kaizar@gmail.com |
| Dr Maheshkumar D Zala |
Krishna Hospital |
Room no - A1, Cardiology Department,
Naroda Road, Opp. Shakti Complex, Mota Chiloda, Gandhinagar-382355
Gandhinagar
GUJARAT |
9898073155
mdzala12@yahoo.co.in |
| Dr C G Agrawal |
Sitara Poly Clinic |
Sitara Poly Clinic,
Cardiology Department,
Room no- A-26, Nirala Nagar
Lucknow
Lucknow
UTTAR PRADESH |
9833009599
cgagrawal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
| Riddhi Medical Nursing Home 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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to provide written informed consent form
2.Male or Female patients aged 18 years and above
3.Essential hypertension which is uncontrolled (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg ) on dual anti-hypertensive agents
4.Patients treated with cilnidipine, metoprolol succinate and chlorthalidone
|
|
| ExclusionCriteria |
| Details |
1. Patients receiving any other antihypertensive other than cilnidipine, metoprolol succinate and chlorthalidone |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Mean Systolic blood pressure
2. Reduction in Mean Diastolic blood pressure
3. Complications
|
1, 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Demographic data of study participants
2.Socioeconomic status of patient
3. Comorbid conditions
4.Preferred Dose of cilnidipine, metoprolol succinate and chlorthalidone
5. Dosage frequency
6. Administration time
7. Concomitant medications
8. Adverse events
|
1, 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is prospective, observational data collection study of the high risk hypertensive patients visiting various clinics across India. High risk hypertensive patients are generally prescribed more than one antihypertensive drugs. We plan to enroll approximately 500 patients from approximately 25 different clinics receiving treatment of cilnidipine, metoprolol succinate and chlorthalidone. The primary objective of the study is to evaluate reduction in systolic and diastolic blood pressure along with treatment emergent complications and secondary objective of the study is to understand demography, Socioeconomic status of patient, Comorbid conditions, Preferred Dose of cilnidipine, metoprolol succinate and chlorthalidone and associated adverse effects.
|