CTRI

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CTRI Number

CTRI/2013/06/003754 [Registered on: 14/06/2013] Trial Registered Prospectively

Last Modified On:

20/05/2019

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study
Modification(s)

Efficacy and safety of Saroglitazar (LipaglynTM) as Compared to Fenofibrate in Patients With Dyslipidemia (PRESS X)].

Scientific Title of Study
Modification(s)

A Multi-centric, Prospective, Randomized, Double- blind, Study to Evaluate the Safety and Efficacy of Saroglitazar (LipaglynTM) 2 and 4 mg as Compared to Fenofibrate 160 mg in Patients With Dyslipidemia.â€

Trial Acronym

ZYH1.12.001.02. PROT

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
ZYH1.12.001.02. PROT,Version 2.0, Dated 27th February 2014.	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name	Dr Deven Parmar
Designation	Vice president
Affiliation	Cadila Healthcare Limited
Address	Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmadabad GUJARAT 382213 India
Phone	91-2717-665555
Fax	91-2717-665355
Email	deven.parmar@zyduscadila.com

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Deven Parmar
Designation	Vice president
Affiliation	Cadila Healthcare Limited
Address	Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmadabad GUJARAT 382213 India
Phone	91-2717-665555
Fax	91-2717-665355
Email	deven.parmar@zyduscadila.com

Details of Contact Person
Public Query
Modification(s)

Name	Dr Deven Parmar
Designation	Vice president
Affiliation	Cadila Healthcare Limited
Address	Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmadabad GUJARAT 382213 India
Phone	91-2717-665555
Fax	91-2717-665355
Email	deven.parmar@zyduscadila.com

Source of Monetary or Material Support

Primary Sponsor

Name	Cadila Healthcare Limited
Address	Zydus Cadila House Plot No. 360, TPS 5, Service Road, Vile Parle (E) Mumbai MAHARASHTRA 400 057 India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NA

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 48
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vipul Khandelwal	Apex Hospitals Pvt Ltd., Jaipur	Apex Hospitals Pvt Ltd.,SP 4 and 6, MIA, Near Apex Circle, Malviya Nagar, Jaipur 302017 Jaipur RAJASTHAN	9829193517 drvipulkhandelwal@gmail.com
Dr Hasmukh Dobaria	Apple Hospital, Surat	Apple Hospital Situated at Udhna Darwaja, Ring Road, Surat 395002 Surat GUJARAT	9925852361 dr.hkdobariya@yahoo.co.in
Dr T Pramod Rao	Aware Global Hospital	Aware Global Hospital ( A unit of Ravindranath GE Medical Associates Pvt Ltd)08-16-01,Sagar Road,Saroornagar,Near L B Nagar,Hyderabad-500035 Hyderabad ANDHRA PRADESH	7207845279 pramodkumarrao@yahoo.co.in
Dr Ashish Kantilal Singwala	BAPS Pramukh Swami Hospital, Surat	BAPS Pramukh Swami Hospital, Adajan Cross Road, NearCountry Club, Surat 395009 Surat GUJARAT	9825312027 ashishsingwalabaps@gmail.com
Dr K N Satish Babu	BGS Hospital, BGS Health & Education City	Consultant-Endocrinologist and Diabetic, BGS Hospital, BGS Health & Education City # 67, Uttarahalli Road, Kengeri, Banglore â€“ 560060 Bangalore KARNATAKA	9731533636 babu09_uk@yahoo.co.uk
Dr Sudhir Bhandari	Bhandari Clinic & Research Centre	Bhandari Clinic & Research Centre, D-126 A, Krishna Marg, University Road, Bapu Nagar, Jaipur 302015 Jaipur RAJASTHAN	9829078844 drs_bhandari@yahoo.com
Dr Meena Shah	Bhatia Hospital,Mumbai	Bhatia Hospital, Tardeo Road, Mumbai â€“ 400 007 Mumbai MAHARASHTRA	9820317747 mushah_2007@rediffmail.com
Dr Manoj Chawla	BSES Municipal General Hospital	BSES Municipal General Hospital, S.V. Road,Opp Railway Station Andheri (W), Mumbai-400058 Mumbai MAHARASHTRA	9820002333 linadiabetes@gmail.com
Dr Praveen Gare	Chopda Medicare & Research Centre Pvt Ltd	Chopda Medicare & Research Centre Pvt Ltd, Magnum Heart Institute, Patil Lane 1 , Canada Corner, Nashik, Maharashtra. Nashik MAHARASHTRA	0253-2316200 drpravingare@rediffmail.com
Dr Sumeet Mandale	Chopda Medicare & Research Centre Pvt Ltd	Magnum Heart Institute, Patil Lane 1 , Canada Corner, Nashik, Maharashtra. Nashik MAHARASHTRA	9921930564 sumeetm3011@gmail.com
Dr Rakesh Kumar Sahay	Department of Endocrinology	Department of endocrinology ,2nd Floor,Golden Jubilee Block,Osmania General Hospital,Afzalgunj,Hydrabad-500012 Hyderabad ANDHRA PRADESH	9849597507 sahayrk@gmail.com
Dr Asha Shah	Department of Medicine, BJ Medical College and Civil Hospital	Department of Medicine, BJ Medical College and Civil Hospital, Ahmedabad 380016 Ahmadabad GUJARAT	9327066349 navneetasha@yahoo.com
Dr Dinesh Jain	Department of Medicine, DMC and Hospital	Department of Medicine, Dyanand Medical College and Hospital, Civil Line, Ludhiana 141001 Ludhiana PUNJAB	9815532533 jaindinesh@yahoo.co.in
Dr V C Srinivas Reddy	Department of Medicine, King George Hospital	Department of Medicine, King George Hospital,Vishakhapatnam 530002 Visakhapatnam ANDHRA PRADESH	9703157774 bioexperts21@gmail.com
Dr Rajendra P Agarwal	Diabetes Care and Research Centre, SP Medical College and AG Hospitals, Bikaner	Diabetes Care and Research Centre, SP Medical College and AG Hospitals, Bikaner 334001 Bikaner RAJASTHAN	0151-2202131 drrpagarwal@yahoo.co.in
Dr Minal Mohit	Diabetes, Obesity, Metabolic and Endocrine Centre, SK Soni Hospital, Jaipur	Diabetes, Obesity, Metabolic and Endocrine Centre, SK Soni Hospital, Sec-5, Vidhyadhar Nagar, Jaipur 302013 Jaipur RAJASTHAN	9783218372 drminal.mohit@gmail.com
Dr Rupam Das	Down Town Hospital, Guwahati	Down Town Hospital,GS Road, Guwahati 781006 Kamrup ASSAM	9864116999 rupamdas_in@yahoo.com
Dr Shrikant Deshpande	Dr. Deshpandes Ashirwad Hospital & Research Centre	Dr. Deshpandes Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata Udhyan, Ulhasnagar, Nashik-422002, Maharashtra, India Nashik MAHARASHTRA	9822017445 writetoshrikant@rediffmail.com
Dr Srikanth Kongara	Endocare Hospital, A Unit of Coastal Endocrine Speciality Hospitals Pvt Ltd.	Endocare Hospital, A Unit of Coastal Endocrine Speciality Hospitals Pvt Ltd., D. No. 29-19-59, Dornanakar Road, Suryaraopet, Vijaywada 520002 Krishna ANDHRA PRADESH	0866-2433306 endulife7@gmail.com
Dr R V Vijay Bhaskar	Global Hospitals	Global Hospitals,6-1-10170 01to 04,Lakdi ka phool,Hyderabad-500004 Hyderabad ANDHRA PRADESH	9848016056 rvbhaskar01@hotmail.com
Dr Urman Dhruv	HCG Multispeciality Hospital, Ahmedabad	HCG Multispeciality Hospital,Mithakhali, Ellisbridge, Ahmedabad 380006 Ahmadabad GUJARAT	9898885522 drurmandhruv@hotmail.com
Dr Satinath Mukhopadhyay	Institute of Post Graduate Medical Education and research	Institute of Post Graduate Medical Education and research, Ronald Ross Building, 4th floor ( Room No : 9, 9A) 244 AJC Bose Road, Kolkata â€“ 700020. Kolkata WEST BENGAL	9830027985 satinath.mukhopadhyay@gmail.com
Dr Sankar Chandar Mondal	IPGMER Kolkata	IPGMER Ronald Ross Building, 4th Floor, Room No. 9, 9A, 244, AJC Bose Road, Kolkata 700020 Kolkata WEST BENGAL	9432142592 drscmandal5@gmail.com
Dr Daya Sagar Rao	KIMS Hospital, Minister Road, Secunderabad	KFRC Ethics Foundation and Research Center,#1-8-31/1, Minister Road, Secunderabad 600003 Hyderabad ANDHRA PRADESH	9849022989 dsraovala@gmail.com
Dr Anirban Mazumder	KPC Medical College and Hospital	KPC Medical College and Hospital, IH, Raja SC Mullik Road, Jadavpur, Kolkata 700032 Kolkata WEST BENGAL	9830078837 dranirbanmazumdar@gmail.com
Dr Thomas Paul	Madonna Hospital and Research Centre	Madonna Hospital and Research Centre, Angamalay, Ernakulam 683572 Ernakulam KERALA	0484-2453466 madonnahospital@rediffmail.com
Dr Laxmikant GOyal	Malpani Multispeciality Hospital, Jaipur	Malpani Multispeciality Hospital,SP-06, Road No. 1, VK1 Industrial Area, Sikar Road, Jaipur 302013 Jaipur RAJASTHAN	9462651019 drlkgoyal@gmail.com
Dr Rajesh Nair	Mar Augustine Golden Jubilee Hospital, Ernakulam	Mar Augustine Golden Jubilee Hospital,PO Mookkannoo, Emakulam 683577 Ernakulam KERALA	0484-2616869 rnair@yahoo.co.in
Dr Dinesh Agarwal	Marwari Hospital & Research Centre	Room No. 3, First Floor, Marwari Hospital & Research Centre, ECRC â€“ HEC Research Unit, S. J. Road, Athgaon, Guwahatiâ€”781008, Assam, India Golaghat ASSAM	0361-2602738 drdinesh944@gmail.com
Dr Manish Agrawal	Medilink Hospital & Research Center	Opp Someshwara Jain Temple, 132 Ft Ring Road,Satellite Ahmadabad GUJARAT	07926762821 medilinkresearchcentre@yahoo.com
Dr Girish Bhatia	Medipoint Hospital Pvt. Ltd	Medipoint Hospital Pvt. Ltd, 241/1, New D. P. Road, Aundh, Pune 411007 Pune MAHARASHTRA	7387003636 Drbhatia.pentagon@gmail.com
Dr Nilanjan Sengupta	Nilratan Sarkar Medical College and Hospital, Kolkata	Nilratan Sarkar Medical College and Hospital, 138 AJC Bose Road, Kolkata 700014 Kolkata WEST BENGAL	033-22653333 drnilanjansengupta@gmail.com
Dr Gaurish Gadbil	Nirmal Hospital Pvt Ltd., Surat	Nirmal Hospital Pvt Ltd., Ring Road, Civil Street, Near Kadiwala School, Surat 395002 Surat GUJARAT	9823654123 dr.gaurishgadbail@gmail.com
Mukund Kumble	Omega Hospital, Mangalore	Omega Hospital,Mahavir Circle, Kankannady, Mangalore 575002 Dakshina Kannada KARNATAKA	9845082811 mukundkumble@hotmail.com
Dr Vikas Pai	Oyester and Pearl Hospital, Pune	Oyester and Pearl Hospital, 671 - 75, Ganeshkhind Road, Shivaji Nagar, Pune - 411005 Pune MAHARASHTRA	9890035437 drpaivikas@gmail.com
Dr Rahul Dosi	Oyster and Pearl Hospital	Oyster and Pearl Hospital, 6th Floor, 1671-75 ganeshkhind road shivaji nagar, Behind Hotel pride Executive, Pune, Maharashtra 411005 Pune MAHARASHTRA	9850038032 drrahuldoshi@gmail.com
Dr Narendra Dedhia	Parakh Hospital and Research Centre, Ghatkopar	Parakh Hospital and Research Centre, Khokani Lane, Opp Ghatkopar Railway Station (E), Mumbai Mumbai MAHARASHTRA	9821132951 narendradedhia@hotmail.com
Dr K Sunil Naik	Rajiv Ghandhi Institute of Medical Science and RIMS Govt. General Hospital	Department of General Medicine, Rajiv Ghandhi Institute of Medical Science and RIMS Govt. General Hospital, Srikakulam 532001 Srikakulam ANDHRA PRADESH	9440828299 rimsresearch@gmail.com
Dr Kamlesh Fatania	Rathi Hospital	Rathi Hospital, Nr. Anupam Shopping Centre, Opp. Mahabaleshwar Socity, Jodhpur cross road, Satellite, Ahmedabad 380015, Gujarat Ahmadabad GUJARAT	9825466788 kamleshfatania23@gmail.com
Dr Liyakat Ali Gauri	Rheumatology Division of Medicine SPMC and PBM Hospital	Rheumatology Division of Medicine SPMC and PBM Hospital, Bikaner 334003 Bikaner RAJASTHAN	9829795116 drliyakatgauri@rediffmail.com
Dr Falguni Iyer	Shalby Hospitals	Opp Karnavati Club, S.G Highway Ahmadabad GUJARAT	9714788339 falguni.iyer@shalby.org
Dr Aniruddha Dharmadhikari	Shree Saibaba Heart Institute and Research Centre	Near Kalidas Kala Mandir, Shalimar, Nashik, 422002 Nashik MAHARASHTRA	9823033646 anipaul@hotmail.com
Dr Pooja Khosla	Sir Ganga Ram Hospital, New Delhi	Sir Ganga Ram Hospital, SGRH Marg, Rajinder Nagar, New Delhi 110060 New Delhi DELHI	9818288194 drpoojakhosla@yahoo.com
Dr Radhey Shyam Chejara	SMS Medical College and Attached Hospital, Department of Internal Medicine	SMS Medical College and Attached Hospital, Department of Internal Medicine, JLN Marg, Jaipur 302004 Jaipur RAJASTHAN	9460539358 drchejara@gmail.com
Dr Rajeev Tiwari	SR Kalla Memorial Gastro and General Hospital	SR Kalla Memorial Gastro and General Hospital, 78-79 Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg C-Scheme, Jaipur 302001 Jaipur RAJASTHAN	9829139517 drrajeevtiwari@rediffmail.com
Dr N Vijay Kumar	Sri Venkateshwara Hospital, Bangalore	Sri Venkateshwara Hospital, 86 Hosur Main Road, Madiwala, Bangalore 560068 Bangalore KARNATAKA	9448116114 drvijayakumar.n01@gmail.com
Dr Praveen Jadhav	Sujata Birla Hospital and Medical Reserach Centre	Sujata Birla Hospital and Medical Reserach Centre, Opp. Bytco College,Nashik Road,Nasik-422101 Nashik MAHARASHTRA	9822055612 drpraveenjadhav@rediffmail.com
Dr S Satyanarayan Murthy	Vijaya Super Speciality Hospital, Nellore	Vijaya Super Speciality Hospital,Raghava Cine Complex Road, Poghthota, Nellore 524001 Nellore ANDHRA PRADESH	8612300068 projectspcr@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 48
Name of Committee	Approval Status
Apex Hospitals Pvt Ltd,	Approved
Apple Hospital Ethics Committee	Approved
Ashirwad Ethics Committee (AEC)	Approved
Bhatia Hospital, Medical Research Society Ethics Committee	Approved
BSES Municipal general hopsital,Ethics committee	Approved
Drug Trial Ethics Committee ,Dayananad Medical College	Approved
ECRS, Hospital Ethics Committee,Marwari Hospital Reserach Centre	Approved
Ethics Committee BJ Medical College and Civil Hopital	Approved
Ethics Committee Down Town Hospital	Approved
Ethics Committee Osmania Medical College	Approved
Ethics Committee Shalby hospital	Approved
Ethics Committee, Sir Ganga Ram Hospital	Approved
Ethics Committee, SP Medical College and AG Hospital	Approved
Ethics Committee,S P Medical College and A G Hospitals	Approved
Ethics committee,Sree Venkateshwara Speciality Hospital	Approved
HCG multispecialty Ethics Committee	Approved
Instituional Ethics Committee, BAPS Pramukh Swami Hospital	Approved
Instituional Ethics Committee, Madonna Hospital and Research centre	Approved
Instituional Ethics Committee, RIMS	Approved
Institutional Ethics Committee BGS Global Hospitals	Approved
Institutional Ethics Committee KPC Medical College and Hospital	Approved
Institutional Ethics Committee, Coastal Endocrine Specialty Hospital	Approved
Institutional Ethics Committee, Global Hospitals, hyderabad	Approved
Institutional Ethics Committee, Global Hospitals, hyderabad	Approved
Institutional Ethics Committee, MAGJ Hospital	Approved
Instiutional Ethics Committee Situated at M/s. King George Hospital, Vishakhapatnam	Approved
IPGMER Research Oversight Committee	Approved
IPGMER Research Oversight Committee	Approved
KFRC Ethics Committee	Approved
Magna Care Ethics Committee	Approved
Magna Care Ethics Committee	Approved
Malpani Multispeciality Hospital	Approved
Medilink Ethics Committee	Approved
Nirmal Hospital Pvt Ltd, Ethics Committee	Approved
NRS Medical College, Institutional Ethics Committee	Approved
O and P Institutional Ethics Committee	Approved
O and P Institutional Ethics Committee	Approved
Omega Ethics Committee Omega Hospital	Approved
Penta-Med Ethics Committee	Approved
Pioneer Ethics Committee Parakh Hospital and Research Centre	Approved
Rathi Ethics Committee	Approved
SEAROC Ethics Committee SK Soni Hospital	Approved
Shree saibaba Ethics Committee	Approved
SR Kalla Memorial Ethical Committee for Human Research SR Kalla Memorial Gastro and General Hospital	Approved
The Chairperson SAEROCK Ethics Committee	Approved
The Ethics Committee SMS Medical and Attached Hospitals	Approved
Vijay Ethics Committee Vijaya Super Speciality Hospital	Approved
Yash Society Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Dyslipidemia, (1) ICD-10 Condition: E785\|\|Hyperlipidemia, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Fenofibrate	Route-Oral Frequency -Once daily Duration -06 Months Dosage :-Fenofibrate 160 Mg
Comparator Agent	Saroglitazar 2 Mg and 4 Mg	Route-Oral Frequency -Once daily Duration -06 Months Dosage :-Saroglitazar 2 Mg 0r 4 Mg

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Subjects age 18- 65 years, of either sex 2. Subjects with hypertriglyceridemia (â‰¥200 mg/dL) at the time of screening and after life style modifications for 6 weeks 3. Both diabetic (type 2 diabetes mellitus; should be HbA1cÂ <9%) and non-diabetic 4. Body mass index (BMI) > 18.5 kg/m2 5. Subject has given informed consent for participation in this trial.

ExclusionCriteria

Details

1. Pregnancy and lactation
2. History of 5% weight loss in past 6 months
3. Subject with diabetes mellitus with HbA1C â‰¥9%
4. Subject with type 1 diabetes
5. Subjects on glitazone / glitazar therapy in the past 3 month.
6. Subject of nutraceuticals within last 3 months
7. Diabetic Ketoacidosis/Hyperosmolar coma
8. Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV)
9. Uncontrolled hypertension (BP160/100 mmHg)
10. History of clinically significant peripheral edema in past 3 months
11. History of uncontrolled thyroid disorder (abnormal TSH value) and not controlled by thyroid modulating drugs
12. History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT â‰¥2.5 times of upper normal limit (UNL) or bilirubin â‰¥2 times UNL
13. Renal dysfunction demonstrated by serum creatinine 1.5 mg/dL or eGFRÂ Â 60Â mL/min/1.73Â m2.
14. History of myopathies or evidence of active muscle diseases demonstrated by CPK â‰¥10 times UNL at screening visit
15. History of Pancreatitis in last 3 months
16. Any other concurrent serious illness within past 5 years (e.g. tuberculosis, HIV, malignancy)
17. History of alcohol and/or drug abuse
18. History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients
19. Subjects on concomitant medications known to affect the lipid level (Appendix 3) other than statins in past 4 weeks (with TGâ‰¥200)
20. History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months
21. Participation in any other clinical trial in the past 3 months

Method of Generating Random Sequence
Modification(s)

Computer generated randomization

Method of Concealment
Modification(s)

Pre-numbered or coded identical Containers

Blinding/Masking
Modification(s)

Double Blind Double Dummy

Primary Outcome

Outcome	TimePoints
To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate	6 weeks, 12 weeks and 24 weeks

Secondary Outcome
Modification(s)

Outcome	TimePoints
To compare the percentage change in lipid parameters (Time frame: 12 and 24 weeks) a. LDL b. VLDL c. HDL d. Total cholesterol e. Non HDL cholesterol f. Apo A1 g. Apo B.	12 weeks and 24 weeks.
To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate 160 mg at Week 6.	Week 06

Target Sample Size

Total Sample Size="1010"
Sample Size from India="1010"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)
Modification(s)

12/03/2015

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

This is A Multi-centric, Prospective, Randomized, Double- blind, Study to Evaluate the Safety and Efficacy of Saroglitazar (Lipaglyn^TM) 2 and 4 mg as Compared to Fenofibrate 160 mg in Patients With Dyslipidemia 24 Week study.