| CTRI Number |
CTRI/2009/091/000683 [Registered on: 23/12/2009] |
| Last Modified On: |
13/11/2018 |
| 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 tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol 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 tablets of Nebivolol & Indapamide (as sustained release) in comparison with Nebivolol tablets in patients suffering from hypertension |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 08-18 |
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 |
| 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. Panna Kamdar |
Govt. Medical College & Sir T. Hospital, Bhavnagar |
Dept. of Medicine,Govt. Medical College & Sir T. Hospital-
Bhavnagar
GUJARAT |
drpam2007@hotmail.com |
| Dr. Parul Bhatt |
Govt. Medical College, Surat |
Dept. of Medicine,Govt. Medical College-
Surat
GUJARAT |
drparulbhatt@yahoo.co.in |
| Dr. Manish Agrawal |
Medilink Hospital, Ahmedabad |
Medilink Hospital,Nr. Shyamal Char Rasta-380015
Ahmadabad
GUJARAT |
079-26762821
079-26765628
|
| Dr Raghvendra Choudhary |
S.P. Medical College and A.G. Hospitals, Bikaner |
Dept. of Medicine,S.P. Medical College and A.G. Hospitals-
Bikaner
RAJASTHAN |
9414262690
drraghven_10@yahoo.com |
| Dr. Jitendra Lakhani |
Smt. Bhikhiben Kanjibhai Shah Medical Institute & Research Centre, Vadodara |
Dept. of Medicine,Smt. Bhikhiben Kanjibhai Shah Medical Institute & Research Centre,-391760
|
02668- 245262
02668- 245292
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee - S.P. Medical College and A.G. Hospitals, Bikaner |
Approved |
| Ethics Committee - Sumandeep Vidyapeeth University |
Approved |
| Human Research Ethics Committee - Govt. Medical College & New Civil Hospital, Surat |
Approved |
| Institutional Review Board (Human Ethics Committee) - Govt. Medical College, Bhavnagar |
Approved |
| Medilink Institutional 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 tablets of Nebivolol 5 mg & Indapamide 1.5 mg (as sustained release) |
Once in a day for 6 weeks |
| Comparator Agent |
Nebivolol 5 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 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, hyponatremia, hypokalaemia, hyperuricemia, secondary hypertension, systemic lupus erythematosus
3. Patients with bronchial asthma, diabetes, thyrotoxicosis, peripheral vascular disease, severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure or sick sinus syndrome
4. Patients with hepatic and /or renal dysfunction
5. Patients with a history of known hypersensitivity to either Nebivolol or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs
6. Patients with any other serious concurrent illness or malignancy
7. Patients with continuing history of alcohol and / or drug abuse
8. 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)
|
10/06/2009 |
| 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="10"
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 tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol 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. |