| CTRI Number |
CTRI/2010/091/000165 [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 two drugs,ZYH1 and Rosiglitazone in diabetic patients with high lipid levels.[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS II)] |
Scientific Title of Study
Modification(s)
|
A 12 week, randomised, double blind parallel group prospective dose ranging study of ZYH1 with an open Rosiglitazone arm to evaluate the efficacy on dyslipidemia in patients with diabetes |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2002 Ver.01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
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 RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
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 RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
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
|
| Cadila Healthcare Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House,
TPS 5, Plot No. 360,
Service Road,
Vile Parle (E),
Mumbai-400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Satinath Mukherjee |
Institute of Postgraduate Medical Education & Research (IPGMER) |
Institute of Postgraduate Medical Education & Research (IPGMER),Department of Endocrinology & Metabolism, IPGMER, 244, A. J. C. Bose Road, -700060
Kolkata
WEST BENGAL |
09830027985,
satinath.mukhopadhyay@gmail.com |
| Dr. Anil Bhansali |
Post-Graduate Institute of Medical Education & Research (PGIMER) |
Post-Graduate Institute of Medical Education & Research (PGIMER),Department of Endocrinology, PGIMER, Sector-12-160012
Chandigarh
CHANDIGARH |
09316977995, 0172 2756583, 0172 2756581 (O), 0712 2744401, 0172 2745078
0172 2744401, 0172 2745078
anilbhansali_endocrine@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr.Anil Bhansali,PG institute of Medical Edn.& research, Chandigarh |
Approved |
| Dr.Satinath Mukherjee,Institute of PG Medical Edn. & research, Kolkata |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Dyslipidemia with Diabetes, (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rosiglitazone 8/16 mg |
one tablet once daily in the morning for the entire duration of the study i.e. for 12 weeks |
| 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 |
|
| Age To |
|
| Gender |
|
| Details |
1.Patients of either sex > or =18 years of age.
2.Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level > or = 150mg/dL.
3.Established diagnosis of Type 2 Diabetes Mellitus with Fasting Blood glucose > or = 126mg/dL (According to American Diabetes Association) with or without on treatment with other hypoglycemic drugs.
4.Normal routine hematological and biochemical test results.
5.Informed consent of the patient / relative.
|
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity to sulpha drugs or ZYH1.
2.Pregnancy & Lactation.
3.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels 2.5 times the upper limit of normal.
4.Patients with history of myopathy or evidence of active muscle disease.
5.Haemoglobin less than 11mg%
6.Patients on concomitant medications known to affect lipid levels and glucose levels and do not want to enter in wash out period.
7.Patients with any other serious concurrent illness or malignancy.
8.Presence or history of gallstone.
9.Patients with continuing history of alcohol and / or drug abuse.
10.Participation in another clinical trial in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| 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
|
| 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="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
02/11/2006 |
| 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
|
Years="1"
Months="6"
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
|
This was a a 12 week, randomized, double blind, parallel group, prospective, dose ranging, and comparative study of ZYH1 with an open Rosiglitazone arm to evaluate the efficacy and safety of oral 0.5, 1, 2 and 4mg ZYH1 as compared to the highest recommended dose of Rosiglitazone ( 8/16 mg daily) on lipid profile and glycemic control in patients suffering from dyslipidemia with diabetes mellitus.
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.
The 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 |