| CTRI Number |
CTRI/2017/09/009786 [Registered on: 15/09/2017] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effectiveness, safety and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in the treatment of hypertension. |
|
Scientific Title of Study
|
Efficacy and tolerability of Fixed Dose Combination of Perindopril plus Indapamide plus Amlodipine in patients with grade II/III hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SER/01/2016 v2.0 dt 20 05 2017amendment 1.0 dt 08 07 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddharth Shah |
| Designation |
National Coordinator |
| Affiliation |
|
| Address |
Bombay mutual terrace,
opera house, V.P. road, Mumbai
Mumbai
MAHARASHTRA
400004
India |
| Phone |
91-022-23612578 |
| Fax |
91-022-23612578 |
| Email |
drsnsonline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sofi Joseph |
| Designation |
Head of Regulatory Affairs & Pharmacovigilance |
| Affiliation |
Serdia Pharmaceuticals (India) Pvt. Ltd |
| Address |
Serdia House, Off Dr. S.S.Rao Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
91-022-24196000 |
| Fax |
91-022-24162735 |
| Email |
sofi.joseph@servier.com |
|
Details of Contact Person
Public Query
|
| Name |
SOFI JOSEPH |
| Designation |
Head of Regulatory Affairs & Pharmacovigilance |
| Affiliation |
Serdia Pharmaceuticals (India) Pvt. Ltd |
| Address |
Serdia House, Off Dr. S.S.Rao Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
91-022-24196000 |
| Fax |
91-022-24162735 |
| Email |
sofi.joseph@servier.com |
|
|
Source of Monetary or Material Support
|
| Serdia Pharmaceuticals (India) Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House, Off Dr. S.S.Rao Road, Parel, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrHemant Thacker |
Bhatia Hospital |
G-1 Block (Ground Floor)
Bhatia Hospital,
Tardeo Road
Mumbai - 400007
Mumbai
MAHARASHTRA |
91-022-23613882
drhpt@hotmail.com |
| Dr Gaurav Chaudhary |
King Georges Medical University |
Dept of cardiology,
Administrative block,
1st Floor,
Research cell,
King Georges Medical University,
Lucknow - 226003,
Uttar Pradesh
Lucknow
UTTAR PRADESH |
9936062507
gauravchaudharydr@gmail.com |
| DrLSreenivasa Murthy |
Lifecare Hospital and Research Centre |
#2748/2152 MLN Enclave, 16th E cross, 8th Main, D Block, Next to corporation bank, Sahakarnagar, Bangaluru - 560092
Bangalore
KARNATAKA |
91-080-23631055
drlsm@lcrc.in |
| DrKMK Reddy |
Osmania Medical College & General Hospital |
Department of Cardiology,
Osmania Medical College & General Hospital,
Afzalgunj, Hyderabad, T.S - 500012, India
Hyderabad
ANDHRA PRADESH |
9848015098
drkmkreddycardio@gmail.com |
| DrJitendra Pal Singh Sawhney |
Sir Gangaram Hospital |
5th floor, Dharma Veera Heart Centre, Rajinder Nagar, New Delhi - 110060
New Delhi
DELHI |
91-011-25224349
jpssawhney@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Clinical Trial Ethics Committee (Bhatia Hospital) |
Approved |
| King Georges Medical University - Institutional Ethics Committee |
Approved |
| Lifecare Hospital and Research Centre |
Approved |
| Osmania Medical College Ethics Committee |
Approved |
| Sir Gangaram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, GRADE II/III HYPERTENSION, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A fixed dose combination of perindopril indapamide and amlodipine (Brand name TRIPLIXAM®) |
2 strengths of FDC Perindopril erbumine 4 mg indapamide 1.25 mg and amlodipine 5 mg AND
Perindopril erbumine 8 mg indapamide 1.25 mg and amlodipine 5 mg
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Uncontrolled grade II and grade III hypertensive patients with a baseline blood pressure > 140/90 mmHg despite receiving any two drug therapy comprising of either ACEI, ARBs, CCBs and diuretics as individual tablets or in combination as a fixed dose combination therapy
2. Patients of either sex
3. With confirmed diagnosis of Grade II/ III (moderate to severe) hypertension, as per ESC 2013 guidelines
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled diabetes (Hba1c% more than 7)
2. H/o myocardial infarction within the previous 3 months
3. H/o cerebrovascular event within previous 3 months
4. Uncontrolled arrhythmias
5. H/o Heart failure
6. Patients with class II/IV heart blocks
7. Patients receiving beta-blockers
8. Patients with known severe impaired renal function (serum creatinine levels 5.3 mg/dl and / or serious liver disorders)
9. Patients unwilling to give informed consent.
10. Patients with known history of hypersensitivity to indapamide or amlodipine or perindopril
11. Any contraindication to Thiazide type diuretic, CCB and ACEI
12. Pregnancy or lactation
13. Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant.
14. Patients previously enrolled in similar or any other trial in the preceding last 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the blood pressure reduction rate in moderate to severe hypertensive patients after treatment with TRIPLIXAM® given once daily in the morning during the study evaluation period. |
Day 15 and Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety and tolerability of TRIPLIXAM® in the treatment of hypertension
|
Day 180 |
| To evaluate the quality of life (QoL) in patients treated with TRIPLIXAM® treatment using WHO QoL tool questionnaire. (WHOQOL-BREF 26-point questionnaire) |
Day 180 |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/11/2017 |
| Date of Study Completion (India) |
31/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
TO BE DECIDED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study will be conducted as per the GCP guidelines and the "Ethical Guidelines for Biomedical Research on Human Participants" issued by ICMR and the other regulations in force in India. The Fixed Dose Combination of perindopril + indapamide + amlodipine, three drugs in a fixed dose combination (FDC) is recently approved in Europe. It is indicated for the treatment of essential hypertension where combination treatment for target blood pressure is recommended. The proposed phase III study is a part of the marketing approval review process in India. The sponsor of the study M/S Serdia Pharmaceuticals (India) Pvt. Ltd wishes to introduce a fixed dose combination with these three widely used antihypertensive drugs from three different therapeutic classes in the following composition: - perindopril erbumine 4 mg + indapamide 1.25 mg + amlodipine 5 mg
- perindopril erbumine 8 mg + indapamide 1.25mg + amlodipine 5 mg
240 patients (35 patients per centre) will be included in the study satisfying the eligibility criteria as per the protocol, with an objective to obtain at least 200 patients completing the study from 5 centres. Scheduled date of start: Sep 2017 (tentative) Scheduled date of completion: May 2019 (tentative) |