| CTRI Number |
CTRI/2014/02/004417 [Registered on: 18/02/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| 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 study of IN-SUPR-002 in Comparison With Fixed Dose Combination (FDC) of Fenofibrate and Rosuvastatin in Patients with Mixed Dyslipidemia |
|
Scientific Title of Study
|
A Randomized, Open Label, Multicentre, Comparative Clinical Trial of IN-SUPR-002 in Comparison with Fixed Dose Combination (FDC) of Fenofibrate and Rosuvastatin in Patients with Mixed Dyslipidemia |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/IN-SUPR-002/DL/III/11; Version 02; 13 Sep 13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Falgun Vyas |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202021 |
| Email |
falgunvyas@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Falgun Vyas |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court
S. G. Highway, Gota
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202021 |
| Email |
falgunvyas@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Harshit Shah |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202067 |
| Fax |
07940202021 |
| Email |
harshitshah@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas pharmaceuticals Ltd. |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat,
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Chopda |
Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute |
Department of Cardiology
Plot no. 3/5, Laxmi Nagar, Patil lane No. 1, Canada Corner, Nasik-422005
Nashik
MAHARASHTRA |
0253-2316200
rush_manoj@yahoo.com |
| Prof Uday Narayan Sarkar |
Health Point multispeciality hospital |
Clinical Research Room, Ground Floor, 21, Prannath Pandit Street, (Opposite Lansdowne Padmapukur)- 700 020.
Kolkata
WEST BENGAL |
9830059128
unsarkar.healthpoint@gmail.com |
| Prof V S Narain |
King Georgs Medical University |
Dept. Of Cardiology, King Georgs Medical University, Chowk- 226003
Lucknow
UTTAR PRADESH |
09415022680
vnarain@yahoo.com |
| Dr Ajit Mullasari |
Madras Medical Mission |
Department of Cardiology,
Room #: L01 (L floor),
No. 4A, Dr. J.J. Nagar, Mogappair-600037
Chennai
TAMIL NADU |
9841271361
icvddoctors@mmm.org.in |
| Dr Laxmikant Goyel |
Malpani Multispeciality Hospital |
SP-6, Road no-1, V.K.I Area, Sikar Road-302013
Jaipur
RAJASTHAN |
9462651019
drlkgoyal@gmail.com |
| Dr Rathindranath Sarkar |
Medical College Kolkatta |
Department of General Medicine, 4th Floor, MCH Building, #88, College Street- 700 073
Kolkata
WEST BENGAL |
9433069803
rnsarkar.cmc@gmail.com |
| Dr Girish Bhatia |
Medipoint Hospitals Pvt. Ltd |
Medicine Department, 241/1, New D. P. Road, Aundh- 411007
Pune
MAHARASHTRA |
020-27298081
drbhatia.pentagon@gmail.com |
| Dr Chetan Patil |
Muktai Hospital |
Ground Floor, Plot No. 11, Shivaji Nagar, Nashik-Pune Road-422006
Pune
MAHARASHTRA |
9822651494
patilchetan@yahoo.com |
| Dr Abhay Gupta |
Nirmal Hospital |
Opp. Gate No. 3, M.L.B. Medical College-284128
Jhansi
UTTAR PRADESH |
09415112888
abhaygupta.dr@gmail.com |
| Dr Anil R Jain |
SAL Hospital |
SAL Hospital and medical institute, 812, 8th Floor, Clinical Research Department, Opposite Doordarshan Tower, Drive-in Road, Thaltej- 380 054,
Ahmadabad
GUJARAT |
9825063284
dranilrjain@yahoo.co.in |
| Dr Aditya Kapoor |
Sanjay Gandhi Postgraduate institute of medical science |
Department of Cardiology, V,16, New Campus, Rae Bareli Rd- 226014
Lucknow
UTTAR PRADESH |
0522-2494970
akapoor65@gmail.com |
| Dr Vinay Bhomia |
Sanjivani Super Speciality Hospital |
Department of General Medicine
1, Uday Park Society, Near Sunrise Park, Vastrapur- 380015.
Ahmadabad
GUJARAT |
9825007385
vgb.sanjivani@gmail.com |
| Dr Damodharan |
Sri Ramachandra Medical Centre |
OPD department
G-block, Ground Floor
No. 1, Ramachandra Nagar, Porur- 600116
Chennai
TAMIL NADU |
9840111622
grajswari@gmail.com |
| Dr Vijaya kumar |
Sri venkateshwara Hospital |
Clinical Research Department, 3rd Floor, Left Wing, Sri Venkateshwara Hospital, #86 Hosur Main Road, Madiwala-560068
Bangalore
KARNATAKA |
9448116114
drvijayakumarn@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Bioethics Cell (Institutional Ethics committee), Dr. Aditya Kapoor |
Approved |
| Health Point Ethics Committee, Prof. Uday Narayan Sarkar |
Approved |
| Institutional Ethics Committee Nirmal Hospital,Dr. Abhay Gupta |
Approved |
| Institutional Ethics committee, Dr. Damodharan |
Approved |
| Institutional Ethics Committee,Dr. Ajit Mullasari |
Approved |
| Intituitional Ethics Committee,Dr. Laxmikant Goyel |
Approved |
| Magna Care Ethics Committee, Dr. Manoj Chopda |
Approved |
| Muktai Hospital Ethics Committee,Dr. Chetan Patil |
Approved |
| Penta-Med Ethics Committee, Dr. Girish Bhatia |
Approved |
| SAL Hospital and medical institute Institutional Ethics Committee, Dr. Anil R Jain |
Approved |
| Sanjivani hospital Ethcis Committee, Dr. Vinay Bhomia |
Approved |
| Sri Venkateshwara Hospital Ethics Committee,Dr. Vijaya kumar |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E786||Lipoprotein deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IN-SUPR-002
[FDC of 135 mg Choline fenofibrate (delayed release) and rosuvastatin 10 mg] capsules |
Dose: One capsule orally,
Frequency: Once daily,
Mode of Administration: Oral,
Duration of treatment: 180 days |
| Comparator Agent |
Rozucor-F [FDC of Fenofibrate 160 mg and rosuvastatin 10 mg tablets of Torrent Pharmaceuticals Ltd]. |
Dose: One tablet orally, Frequency: Once daily,Mode of Administration: Oral,Duration of treatment: 180 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Between age of 18 to 70 years
2. Serum triglycerides between 150 mg/dl and 500 mg/dl
3. Serum LDL-C > 100 mg/dl
4. Serum HDL-C < 40 mg/dl for men and < 50 mg/dl for women
5. Willing to give their informed consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant, lactating women or women of childbearing age who are not
using an acceptable method of birth control.
2. Patients with type 1 diabetes mellitus.
3. Patients with thyroid dysfunction.
4. Patients with hypersensitivity to rosuvastatin, fenofibric acid or
fenofibrate.
5. Patients who are chronic alcoholic (> 20 ml of alcohol/day)
6. Patients on treatment of spironolactone and cimetidine
7. Patients with renal dysfunction: Serum creatinine > 1.5 mg/dl. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % Change in serum triglycerides |
At the end of study as compared to baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
% Change in LDL-C
% Change in HDL-C
% Change in total cholesterol
% Change in VLDL-C |
At the end of study as compared to baseline |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2014 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Around the world, cardiovascular disease (CVD) is the leading cause of deaths for adults. The most important modifiable cardiovascular risk factors are smoking, hypertension, dyslipidemia, obesity and hyperglycemia. These risk factors are often clustered, particularly for patients with type 2 diabetes and/or metabolic syndrome. Among dyslipoproteinemia, mixed or combined hyperlipidemia is a common disorder, occurring in about 30% of myocardial infarction (MI) survivors. The aim of this study is to evaluate the safety and efficacy of IN-SUPR-002 in comparison with FDC of fenofibrate and rosuvastatin in treatment of patients with mixed dyslipidemia. The study will be carried out in 240 Patients of either sex between 18 and 70 years of age suffering from mixed dyslipidemia enrolled across India. Both the treatment groups will be compared at the end of treatment. |