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CTRI Number  CTRI/2010/091/000467 [Registered on: 10/05/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Rosuvastatin + Fenofibrate Tablets in the Management of Patients with Mixed Dyslipidaemia. 
Scientific Title of Study   Comparative, Randomised, Double Blind, Parallel, Multicentric Study of Efficacy and Safety of Rosuvastatin + Fenofibrate Fixed Dose Combination Versus Atorvastatin + Fenofibrate Fixed Dose Combination in the Management of Patients with Mixed Dyslipidaemia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPT-NIMS - HETERO / 09/ 06, Version-2  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Shobha Jagadish Chandra  
Designation   
Affiliation   
Address  Dept. of CP&T, Nizam's Institute of Medical Sciences
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  04023355600   
Fax  04023355600   
Email  jcshobha@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Dr. Shobha Jagadish Chandra  
Designation   
Affiliation  NIMS  
Address  Dept. of CP&T, Nizam's Institute of Medical Sciences
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  04023355600   
Fax  04023355600   
Email  jcshobha@yahoo.com   
 
Details of Contact Person
Public Query  
Name  B Mohan Reddy  
Designation   
Affiliation   
Address  Hetero Drugs Ltd, Plot NO 80, 81
APIE Balanagar
Hyderabad
ANDHRA PRADESH
500037
India 
Phone  04023778611   
Fax  04023778011   
Email  b_mohanreddy@heterodrugs.com   
 
Source of Monetary or Material Support  
Hetero Labs Limited (Hyderabad) 
 
Primary Sponsor  
Name  Hetero Labs Limited  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Niranjan M. Rathod  Apex Hospital  S.No. 517A/13, Plot No. 27,Near Gadre Garden, Shivaji Park-416003
Kolhapur
MAHARASHTRA 		 2312646268

niranjanrathod@hormail.com 
Dr. Nilesh Patel  Ashirwad Hospital  3, New Rajendra park,Viratnagar Road, Oclav-382415
Ahmadabad
GUJARAT 		 32570376

drnm7878@yahoo.com 
Dr.B.Bakthavatsalam   Chellam Hospital  Vijayaragavachari Road,-636007
Salem
TAMIL NADU 		 0427 -2319395, 2319396

drbb@gmail.com 
Dr. Nirmit V. Yajnik  Dr. B. R. Patel Hospital  Pratap Road, Dandia Bazar,-390 001
Vadodara
GUJARAT 		 0265-2426112

dr_nvyajnik@yahoo.com 
Dr. S. Sreenivas  King George Hospital  Bhavanagar Ward ,-530002
Visakhapatnam
ANDHRA PRADESH 		 0891-2718471

muralidhargudla@yahoo.com 
Dr. Charles .S. Manian   Lourd Hospital  ,Kannur-670141

 		 4602205453

charlessmanian@yahoo.com 
Dr. M. Rajesh kumar  Narayana Hospital  Dept. of Gen. Medicine,-254002
Nellore
ANDHRA PRADESH 		 0861-2304077

merigsrajeshkumar@gmail.com 
Dr. G. Lepakshi,  S.V.R.R. Govt. General Hospital  Accident Surgery,-517501

 		 0877-2231803

glepakshmi@yahoo.com 
Dr. Manjusha Sunit Yadav   Shreenath Hospital  Uttans Building, Anandvan Complex,New IPCC Road, Subhanpur, -390023
Vadodara
GUJARAT 		 0265-2395055

yadav.manjusha@gmail.com 
Dr. Vipin Kumar Jain   SK Sony Hospital   Janak,1/634 Vidhyadhar Nagar-302023
Jaipur
RAJASTHAN 

jainvipin17@hotmail.com 
Dr. B. Peraiah Chowdary   Sri Krishna Institute of Medical Sciences  Beside Manipuram Flyover,Mangalagiri Road-522 001
Guntur
ANDHRA PRADESH 		 0863-2225777

peraiah1@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Clinicom Ethics Committee For Dr. B. Peraiah Chowdary Sri Krishna Institute of Medical Sciences  Approved 
Clinicom Ethics Committee For Dr. BINS M. John Jubilee Mission Medical College  Approved 
Clinicom Ethics Committee For Dr. Charles .S. Manian Lourd Hospital  Approved 
Clinicom Ethics Committee For Dr. G. Lepakshi S.V.R.R. Govt. General Hospital  Approved 
Clinicom Ethics Committee For Dr. Gautam Bhandari Manidhari Hospital  Approved 
Clinicom Ethics Committee For Dr. M. Rajesh kumar Narayana Hospital  Approved 
Clinicom Ethics Committee For Dr. Manjusha Sunit Yadav Shreenath Hospital  Approved 
Clinicom Ethics Committee For Dr. N. Senthilvel Sri Ramakrishna Hospital  Approved 
Clinicom Ethics Committee For Dr. Nilesh Patel Ashirwad Hospital  Approved 
Clinicom Ethics Committee For Dr. Niranjan M. Rathod Apex Hospital  Approved 
Clinicom Ethics Committee For Dr. Nirmit V. Yajnik Dr. B. R. Patel Hospital  Approved 
Clinicom Ethics Committee For Dr. Vipin Kumar Jain SK Sony Hospital  Approved 
Clinicom Ethics Committee For Dr.B.Bakthavatsalam Chellam Hospital  Approved 
Institutional Ethics committee Dr. S. Sreenivas King George Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mixed Dyslipidaemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A FDC of Atorvastatin 10mg + Fenofibrate 160mg  Atorvastatin 10mg + Fenofibrate 160mg,once daily, Duration 12 weeks 
Intervention  A FDC of Rosuvastatin 10mg + Fenofibrate 160mg  Rosuvastatin 10mg + Fenofibrate 160mg,once daily, Duration 12 weeks 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Subjects of both sexes aged between 18-65 years will be included in the study. Patients lipid results after 10-12 hour fasting interval including: LDL-C > 130mg/dl TG >150mg/dl HDL ? C < 40mg / dl for men and < 50 mg / dl for women ?Mixed dyslipidaemia Naive subjects / with or without dietary counselling (OR) ?Subjects receiving treatment with starting dose of other lipid lowering therapies, but who have failed to achieve the LDL-C goal levels as per NCEP ATP III guidelines  
 
ExclusionCriteria 
Details  ?Patients unwilling or unable to give informed consent ?Patients with secondary hypercholesterolemia, known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoprotenaemia) ?Patients with uncontrolled diabetes (i.e. fasting blood sugar > 140 mg/dl), nephrotic syndrome, myeloma, obstructive liver disease, hypothyroidism, alcoholism ?Patients with clinically significant gastrointestinal, respiratory, hepatic, renal or haematological disorder or any other severe concurrent illness, major surgery or acute infection, gram negative sepsis, extensive burns or cancer within past 5 years ?Patients with unstable angina, severe heart failure, cardiac arrhythmias, myocardial infarction, coronary artery bypass surgery, coronary angioplasty within three months prior to inclusion in the study. ?Patients with suspected bilateral renal artery stenosis, single kidney. ?Patients with active liver disease or hepatic dysfunction as defined by elevations of SGOT or SGPT > 1.5 times the ULN, alkaline Phosphatase or total serum bilirubin > 1.2 times ULN, serum creatinine >1.2 mg/dl or creatinine phosphokinase &#61619;1.5 times ULN ?Patients requiring treatment with potent CYP3A4 inhibitors like cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin ?Patients who had experienced unexplained muscle pain, tenderness or weakness with any other medication of statin group previously ?Pregnant women, women who are breast feeding, and women of childbearing potential not using medically accepted methods of contraception ?Participation in another investigational drug trial within the previous 4 weeks ?Subjects randomised to treatment who subsequently withdraw cannot re-enter this trial ?Subjects with serious or unstable medical or psychological condition that in the opinion of the investigator would compromise the subject?s safety or successful participation in the trial. ?NACP target reach  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study.  0,4,8 & 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study  0,4,8 & 12 weeks 
 
Target Sample Size   Total Sample Size="227"
Sample Size from India="" 
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 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   1. This is a Comparative, Randomized, Double blind, Parallel, Multicentric study for Efficacy and Safety of Rosuvastatin+ Fenofibrate versus Atorvastatin + Fenofibrate in the Management of Patients with Mixed Dyslipidaemia. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the Screening) and data will be submitted 200 completed patients. Study population will comprise of Patients with Mixed Dyslipidaemia. 3. The recommended dose of Rosuvastatin in dose of 10mg + Fenofibrate in dose of 160mg in comparison with Atorvastatin in the dose of 10mg + Fenofibrate in dose of 160mg once daily for 12 weeks. 4. The primary efficacy outcome will be Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.  
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