FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/000164 [Registered on: 09/03/2010]
Last Modified On: 21/05/2019
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 ZYH1 and Fenofibrate in patients with high lipid levels.(Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS I).  
Scientific Title of Study
Modification(s)  		 A 12 week, randomized, double blind parallel group prospective dose ranging study of ZYH1 with an open fenofibrate arm to evaluate the efficacy on dyslipidemia in patients without diabetes. 
Trial Acronym  NA 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2001 Ver.01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr RHJani 
Designation  Sr. Vice President, Clinical R&D 
Affiliation   
Address  Cadila Healthcare limited, Zydus Cadila House
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India 
Phone  91-22-26186052  
Fax  91-22-26151735  
Email  rhjani@zyduscadila.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr RHJani 
Designation  Sr. Vice President, Clinical R&D 
Affiliation  Cadila Healthcare Limited 
Address  Cadila Healthcare limited, Zydus Cadila House
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India 
Phone  91-22-26186052  
Fax  91-22-26151735  
Email  rhjani@zyduscadila.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr RHJani 
Designation  Sr. Vice President, Clinical R & D 
Affiliation   
Address  Cadila Healthcare limited, Zydus Cadila House
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India 
Phone  91-22-26186052  
Fax  91-22-26151735  
Email  rhjani@zyduscadila.com  
 
Source of Monetary or Material Support
Modification(s)  
Cadila Healthcare Limited 
 
Primary Sponsor
Modification(s)  
Name  Cadila Healthcare Limited 
Address  Cadila Healthcare Limited, Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing, Vile Parle (E), Mumbai-400057,India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
None   
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Alaka Deshpande  Grant Medical College & Sir J J Gr. of Govt. Hospital   Department of Internal Medicine, Grant Medical College & Sir J.J. Gr. of Govt. Hospitals, ,2nd Floor, Main Building, Byculla-400008
Mumbai
MAHARASHTRA 		 09869168886, 022 23703696
022 23703696
alakadeshpande@rediffmail.com 
Dr. Tiven Marwah   Le Bonheur Endocrine & Diabetes Clinic  Le Bonheur Endocrine & Diabetes Clinic,107, 2nd Floor, Mahakant Complex, Opp. V. S. Hospital, Ashram Road-380006
Ahmadabad
GUJARAT 		 0272-26576727, 26576737, 09824055857

tiven_marwah@hotmail.com 
Dr. Vikas Pai  Pai Clinic & Diagnostic Centre   Pai Clinic & Diagnostic Centre ,Abhinav Apartments, Shivajinagar, Next to Congress House, Pune; -411005
Pune
MAHARASHTRA 		 09890035437, 020-25534404, 25534944
020 25679919
paivikas@indiatimes.com 
Dr. Keyur Parikh  The Heart Care Clinic  The Heart Care Clinic, ,201-Balleshwar Avenue, Opp. Rajpath Club, S. G. highway-380 015
Ahmadabad
GUJARAT 		 9825026999, 079- 26872620
079-26872620
keyur.parikh@heartcareclinic.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Dr.Keyur Parikh, Ethics Committee-Heart care clinic  Approved 
Dr.Tiven Marwah,Sheth V.S.General hospital, Ahmedabad  Approved 
Dr.Vikas Pai,Mahalasa Independent Ethics Committee  Approved 
Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Dyslipidemia without diabetes mellitus, (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Fenofibrate 160 mg  Frequency- once daily Dosage-160mg Route-Oral 
Intervention  ZYH1 0.5mg, 1mg, 2mg and 4mg   one tablet once daily of either 0.5mg, 1mg, 2mg or 4mg in the morning for the entire duration of the study i.e. for 12 weeks. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of either sex 18 years of age.
Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level  150mg/dL.
Normal routine hematological and biochemical test results.
Informed consent of the patient / relative 
 
ExclusionCriteria 
Details  1.Hypersensitivity to sulpha drugs or ZYH1 2.Pregnancy & Lactation. 3.Patients with the active liver disease or hepatic dysfunction indicated by AST or ALT levels > or = 2.5 times the upper limit of normal. 4.Patients with the history of myopathy or evidence of active muscle disease. 5.Haemoglobin less than 11mg% 6.Patients on concomitant medications known to affect the lipid levels and who does not want to enter in the wash out period. 7.Patients with uncontrolled diabetes mellitus (fasting blood sugar > or =110 mg/dL). 8.Patients with any other serious concurrent illness or malignancy. 9.Presence or history of the gall stone. 10.Patients with continuing history of alcohol and / or drug abuse. 11.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)  		 On-site computer system 
Blinding/Masking
Modification(s)  		 Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose.  From baseline, visit 2(Week 0)to visit 8 (Week 12) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Secondary efficacy endpoints:
1.HbA1C,
2.Insulin and
3.C-Reactive protein(CRP)
 		 From baseline, visit 2 (Week 0)to visit 8 (Week 12) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 2 
Date of First Enrollment (India)
Modification(s)  		 08/08/2006 
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)  		 NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This was a Phase II, 12-Weeks, multicentre, double-blind, randomized, parallel group, prospective study with an open fenofibrate arm in male and female outpatients aged ≥ 18 years, comparing four doses (0.5 mg, 1 mg, 2 mg and 4 mg) of ZYH1 with the 160 mg dose of fenofibrate on lipid profile in subjects with dyslipidemia without type 2 diabetes. The Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose. Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP) The efficacy variables were assessed as percent change at the end of treatment phase i.e., Week 12, as compared to start of treatment phase i.e., Week 0 
Close