| CTRI Number |
CTRI/2017/07/009160 [Registered on: 28/07/2017] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate clinical acceptability of the Fixed Dose Combination of Perindopril + Indapamide in moderate to severe hypertension |
|
Scientific Title of Study
|
Evaluation of clinical acceptability of the Fixed Dose Combination of Perindopril + Indapamide in moderate to severe hypertension |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SER/02/2016 version 5.0 dated 20 May 2017 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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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 India
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| 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 India
Mumbai
MAHARASHTRA
India
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sofi.joseph@servier.com |
|
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Source of Monetary or Material Support
|
| Serdia Pharmaceuticals India Pvt Ltd
Serdia House, Off Dr. S.S. Rao Road, Parel, Mumbai
400 012
Tel no.: 022-24196000
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Primary Sponsor
|
| Name |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House, Off Dr. S. S. Rao road, behind M.G.M. Hospital, Parel, Mumbai - 400012 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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|
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddharth Shah |
BHATIA HOSPITAL |
Medical Research Society, Basement, Tardeo Road,
Mumbai – 400007
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
022-23612578
drsnsonline@gmail.com |
| Dr Sanjay Kalra |
Bharti Research Institute of Diabetes and Endocrinology (BRIDE) |
Department of Clinical research, Kunjpura Road, Model town, Near State Bank of India, Karnal - 132001, Haryana
Karnal
HARYANA
Karnal
HARYANA |
09896048555
brideknl@gmail.com |
| Dr Aravind S R |
DIACON HOSPITAL |
# 359 - 360, Diabetes Care & Research Centre, 19th Main, 1st Block, Rajajinagar, Diacon Hospital, Bengaluru - 560010
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
91-80-23323560
draravind@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bhatia Hospital Medical Research Society Ethics Committee |
Approved |
| CONSCIENCE INDEPENDANT ETHICS COMMITTEE |
Approved |
| ETHICS COMMITTEE-DIACON HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Conditions |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination of Perindopril & Indapamide |
a Treatment initiation dose: FDC of perindopril 4 mg & indapamide 1.25 mg one tablet daily in the morning
b Up-titration dose: FDC of perindopril 8 mg & indapamide 2.5 mg one tablet daily in the morning
|
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mm Hg
2. Patients of either sex with age group of 18 to 65 years of age
3. Uncontrolled hypertensive patients with a baseline blood pressure > 140/90 mmHg on monotherapy and/or any other two drug FDC
4. Newly diagnosed hypertensive patients with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg)
5. Hypertensive patients either on monotherapy / any other FDC with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg)
6. Patients of either sex with confirmed diagnosis of grade II and above (moderate to severe) hypertension, as per ESC guidelines
7. Ready to provide informed consent and available for follow-up
|
|
| ExclusionCriteria |
| Details |
1. H/o myocardial infarction within the previous 3 months.
2. H/o cerebrovascular event within previous 3 months.
3. Uncontrolled arrhythmias.
4. Uncontrolled diabetes (Hba1c% more than 7)
5. H/o heart failure
6. Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders
7. Patients unwilling to give informed consent
8. Patients with history of hypersensitivity to Perindopril or Indapamide
9. Any contraindication to ACE I and/or Thiazide type diuretic
10. Patients receiving beta blockers for the treatment of hypertension
11. Pregnancy or lactation
12. Patients with any other condition or disease, which in the opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant
13. Patients previously enrolled in similar trial in the last 3 months
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
The blood pressure reduction rates from baseline to the end of study with the treatment of the FDC of Perindopril + Indapamide
Mean decrease in blood pressure from the baseline in terms of achieving target BP control ≤140/90 mmHg (among diabetic patients ≤140/85 mmHg as per ESH/ESC 2013 guidelines).
|
DAY 90
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| ² Tolerability and acceptability of the treatment in terms of incidence of side effects and treatment compliance |
DAY 15 AND DAY 90 |
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "133"
Final Enrollment numbers achieved (India)="133" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
28/08/2017 |
| Date of Study Completion (India) |
22/10/2018 |
| 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 |
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Publication Details
|
TO BE DECIDED |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The available clinical evidence today provides the guidelines to initiate the two-drug therapy in patients with moderate to severe hypertension (Systolic BP above 160 mmHg and / or Diastolic BP above 100 mmHg). The fixed dose combination of Perindopril erbumine + Indapamide is marketed worldwide including India by the sponsor of this study under the brand name COVERSYL®PLUS. It is a well-accepted and well prescribed product for the treatment of hypertension. The recent introduction of higher strength of this combination is being evaluated in terms of its clinical acceptability in the proposed phase IV study. This higher strength of the FDC of Perindopril 8 mg + Indapamide 2.5 mg is marketed under the trade name COVERSYL® PLUS HD (approved by the authorities in the year 2014). In this proposed study, the aim of the study is to evaluate the clinical acceptability of the higher strength of the FDC of Perindopril 8mg + Indapamide 2.5 mg in the treatment of hypertension. |