| CTRI Number |
CTRI/2011/04/001689 [Registered on: 21/04/2011] Trial Registered Retrospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effectiveness and safety of two medications in patients suffering from dyslipidemia (abnormal lipid levels in blood) |
|
Scientific Title of Study
|
A randomized, open label, phase III, comparative, multicentric study to assess the efficacy and safety of Fenofibric acid delayed release capsules versus Fenofibrate tablets in patients with dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 10-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Medical Advisor & Head - Regulatory Affairs,
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868211 |
| Fax |
079-26862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kubavat |
| Designation |
|
| Affiliation |
|
| Address |
Sr. Manager - Clinical Research & Regulatory Affairs, Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kubavat |
| Designation |
|
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd., Zydus Tower, Satellite Cross-roads, Ahmedabad - 380015, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross-roads, Ahmedabad - 380015, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 |
| Dr Navneet Agrawal |
Diabetes, Obesity and Thyroid Centre |
Diabetes, Obesity and Thyroid Centre, 19, Hospital Road, Lalitpur Colony, Gwalior.
Gwalior
MADHYA PRADESH |
0751-3206777
navneetdotc@gmail.com |
| Dr Puneet Rijhwani |
K2 Clinic |
K2 Clinic, 14/201, Malviya Nagar, JAIPUR-302 017.
Jaipur
RAJASTHAN |
09314503514
puneet284@rediffmail.com |
| Dr Manish Agrawal |
Medilink Hospital & Research Centre |
Medilink Hospital & Research Centre, Shyamal Cross-roads, Satellite, Ahmedabad - 380015.
Ahmadabad
GUJARAT |
079-26761715
medilinkresearchcentre@yahoo.com |
| Dr V B Singh |
S.P. Medical College and A.G. Hospitals, Bikaner |
Department of Medicine, S.P. Medical College and A.G. Hospitals, Bikaner-334003.
Bikaner
Bikaner
RAJASTHAN |
0151-2226300
vbsingh2@rediffmail.com |
| Dr Praveen Garg |
Shashwat Hospital & Research Centre |
Shashwat Hospital & Research Centre, 323-Satyam Mall, Opp. Kameshwar School, Jodhpur cross roads, Ahmedabad - 380015.
Ahmadabad
GUJARAT |
079-26741500
praveen_k_garg@yahoo.com |
|
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 |
| IEC - Aditya for Dr. Navneet Agrawal |
Approved |
| IEC - Aditya for Dr. Praveen Garg |
Approved |
| IEC - Aditya for Dr. Puneet Rijhwani |
Approved |
| Medilink Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fenofibrate 160 mg tablets |
One tablet once daily for entire study duration of 12 weeks |
| Intervention |
Fenofibric acid 135 mg delayed release capsules |
One capsule once daily for entire study duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with hypertriglyceridemia at the time of enrollment
2. Informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures.
2. Patients already receiving drugs belonging to the fibric acid derivatives.
3. Patients with hepatic or renal dysfunction.
4. Patients with history of myopathy or evidence of active muscle disease.
5. Patients with any other serious concurrent illness or malignancy.
6. Patients with continuing history of alcohol and / or drug abuse.
7. Patients with persistent gall bladder diseases.
8. Patients with known hypersensitivity to fenofibric acid.
9. Participation in another clinical trial in the past 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean percentage change from baseline in the serum Triglycerides (TGs) at the end of the treatment phase |
At baseline (Week 0) and at the end of study (Week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) The mean percentage change from baseline in other lipid profile at the end of the treatment phase
2) Evaluation of global efficacy by the investigator |
At baseline (Week 0) and at the end of study (Week 12) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2011 |
| 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
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)
|
Open label, randomized, phase III, multicentric
study.
Comparison of efficacy and safety of
Fenofibric acid delayed release capsules verses Fenofibrate tablets in the
Indian dyslipidemic patients.
Primary outcome of the study was the
mean percentage change from baseline in the serum Triglycerides (TGs) at the
end of the treatment phase.
Fenofibric
acid delayed release capsules have a comparable therapeutic efficacy as
Fenofibrate tablets in Indian patients suffering from dyslipidemia.
On the tolerability front Fenofibric
acid delayed release capsules were as well tolerated as Fenofibrate tablets. |