| CTRI Number |
CTRI/2010/091/000122 [Registered on: 25/03/2010] |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical study to evaluate the safety and efficacy of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg tablet in mild, moderate and severe hypertensive patients. |
Scientific Title of Study
Modification(s)
|
A phase III, multicenter, open label, single treatment clinical study to evaluate the safety and efficacy of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg tablet in mild, moderate and severe hypertensive patients. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ECTS/09/004 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, Devipark,
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, Devipark,
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, Devipark,
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Vapi Care Pharma Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Vapi Care Pharma Pvt Ltd |
| Address |
Plot No. 225/3, GIDC, Nr. Morarji Circle, Vapi- 396195.
Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Jay Shah |
Life Care Institute of Medical science |
Nr. Sardar Patel Statue,Naranpura-380014
Ahmadabad
GUJARAT |
079-40204020
jayshah08@yahoo.co.in |
| Dr. Omprakash Modi |
Modi Clinic |
Sabina Appt.,,Ellisbridge-380006
Ahmadabad
GUJARAT |
079-26582680
|
| Dr. Akhil Mukim |
Mukim Medical Nursing Home |
235, Platinum Plaza,Bodakdev-380054
Ahmadabad
GUJARAT |
079-26853785
drmukim@indiatimes.com |
| Dr. N.B.Auti |
Om Navjivan Hospital |
Plot no. 2, Sector-21,Khargar-410210
Mumbai
MAHARASHTRA |
022-27740459
|
| Dr MLShukla |
Shuklas Hospital |
Nr. Alankar Cinema,M.G.Road, Bardoli, Dist., Surat-394602
Surat
GUJARAT |
02622-220235
drshukla99@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Akhil Mukim |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Jay Shah |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Mahesh Shukla |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. N. B. Auti |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Om Prakash Modi |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I159||Secondary hypertension, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg |
Orally once daily for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Written informed consent from the patient.
-Male and female patients with age above 18 years inclusive.
-Diagnosis of mild, moderate & severe hypertensive patients with or without concomitant diabetes.
-Patients who will be uncontrolled on monotherapy with or without diabetes mellitus will be included in this study.
|
|
| ExclusionCriteria |
| Details |
-Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
-Known or suspected secondary hypertension.
-Patient with history of asthma or angina.
-Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
-Known hypersensitivity to Telmisartan, Amlodipine and Hydrochlorthiazide.
-Patient who is consuming/ has received drugs, which have interaction with Telmisartan, Amlodipine and Hydrochlorthiazide, during last 14 days.
-Participation in any other clinical trial during last 30 days.
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Reduction in blood pressure for FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg Tablet |
12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Percentage of patients with significant reduction in blood pressure of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg Tablet |
12 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "203"
Final Enrollment numbers achieved (India)="203" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/03/2010 |
| Date of Study Completion (India) |
04/08/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Phase III, Multicenter, Open Label, Single Treatment Clinical Study To Evaluate The Safety And Efficacy Of FDC Of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg Tablet In Mild, Moderate & Severe Hypertensive Patients. After inclusion of patients in the trial the blood pressure measurement will be done at baseline, and then every 2 weeks till normalisation of blood pressure up to maximum of 12 weeks. |