| CTRI Number |
CTRI/2009/091/000863 [Registered on: 06/01/2010] |
| Last Modified On: |
27/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of two drugs, fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets in patients with hypertension. |
Scientific Title of Study
Modification(s)
|
An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) in comparison with Telmisartan tablets in patients suffering from hypertension |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Project No.: 08-17 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, 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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G C Rajadhyaksha |
B. L. Nair Hospital & T. N. Medical College, Mumbai |
Dept. of Medicine,B. L. Nair Hospital & T. N. Medical College-
Mumbai
MAHARASHTRA |
9821695349
girishraj63@hotmail.com |
| Dr. Simmi Dube |
Gandhi Medical College & Associated Hospital, Bhopal |
Dept. of Medicine,Gandhi Medical College & Associated Hospital-
Bhopal
MADHYA PRADESH |
0755 ?2458017
simmi33@yahoo.com |
| Dr. Paresh Gohel |
Kakadiya Hospital, Ahmedabad |
Kakadiya Hospital,L.B. Shastri Marg, Bapunagar-380025
Ahmadabad
GUJARAT |
kiranparesh@yahoo.co.in |
| Dr. P.G. Raman |
Mayur Hospital & Research Centre, Indore |
Consultant Physician,Mayur Hospital & Research Centre-452016
Indore
MADHYA PRADESH |
drpgraman@yahoo.com |
| Dr. Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
Consultant Physician,Shashwat Hospital & Research Centre-380015
Ahmadabad
GUJARAT |
praveen_k_garg@yahoo.com |
| Dr. Nirmit Yajnik |
Shivam Clinic, Vadodara |
Shivam Clinic,109-111, cascade complex, Near Chhani jakat naka-390002
Vadodara
GUJARAT |
dr_nvyajnik@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee - B. Y. L. Nair Hospital & T. N. Medical College |
Approved |
| Ethics Committee - Gandhi Medical College & associated Hospital, Bhopal |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Maanav health foundation - Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, Hypertension, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed-dose combination capsules of Telmisartan 40 mg & Indapamide 1.5 mg (as sustained release) |
Once in a day for 6 weeks |
| Comparator Agent |
Telmisartan 40 mg tablets |
Once in a day for 6 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
2. Patients with hypertension (defined as supine systolic and/or diastolic blood pressure more than 140 mm Hg and 90 mm Hg respectively)
3. Informed consent of the patient/relative |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or Lactation
2. Patients with anuria, progressive & severe oliguria, hepatic coma, hypokalaemia, hyponatremia, hypochloremia, volume depletion, hyperuricaemia, secondary hypertension, congestive heart failure, systemic lupus erythematosus.
3. Patients with hepatic and /or renal dysfunction or bilateral renal artery stenosis.
4. Patients with a history of known hypersensitivity to either Telmisartan or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs
5. Patients with any other serious concurrent illness or malignancy
6. Patients with continuing history of alcohol and / or drug abuse
7. Participation in another clinical trial in the past 3 months |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0) |
2,4 & 6 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of reduction in supine systolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0) |
2,4 & 6 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets given once a day for 6 weeks in 200 patients with hypertension that will be conducted in India. The primary outcome measures will be the degree of reduction in supine diastolic blood pressure at the end of the study as compared to the baseline. |