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CTRI Number  CTRI/2011/11/002133 [Registered on: 16/11/2011] Trial Registered Retrospectively
Last Modified On: 23/01/2013
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study of the cholesterol lowering efficacy and safety of 3 doses of Rosuvastatin (5mg, 10mg and 20 mg)in patients with Indian patients with high cholesterol levels. 
Scientific Title of Study   A prospective, open-label, multi-center, post-marketing study to evaluate the lipid altering efficacy and safety of approved dose ranges of Rosuvastatin in Indian patients in routine clinical practice 
Trial Acronym  ROSUVEES 
Secondary IDs if Any  
Secondary ID  Identifier 
ROSUVAS-001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navneet Wadhwa 
Designation  Medical Advisor 
Affiliation  Ranbaxy Laboratories Ltd 
Address  Ranbaxy Laboratories Limited, Western Edge-1, Unit No. 201-204, 2nd Floor, Western Express Highway, Borivali East, Mumbai 400066

Mumbai
MAHARASHTRA
400066
India 
Phone  9930495588  
Fax  022-28947101  
Email  navneet.wadhwa@ranbaxy.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Navneet Wadhwa 
Designation  Medical Advisor 
Affiliation  Ranbaxy Laboratories Ltd 
Address  Ranbaxy Laboratories Limited, Western Edge-1, Unit No. 201-204, 2nd Floor, Western Express Highway, Borivali East, Mumbai 400066

Mumbai
MAHARASHTRA
400066
India 
Phone  9930495588  
Fax  022-28947101  
Email  navneet.wadhwa@ranbaxy.com  
 
Details of Contact Person
Public Query  
Name  Dr Navneet Wadhwa 
Designation  Medical Advisor 
Affiliation  Ranbaxy Laboratories Ltd 
Address  Ranbaxy Laboratories Limited, Western Edge-1, Unit No. 201-204, 2nd Floor, Western Express Highway, Borivali East, Mumbai 400066

Mumbai
MAHARASHTRA
400066
India 
Phone  9930495588  
Fax  022-28947101  
Email  navneet.wadhwa@ranbaxy.com  
 
Source of Monetary or Material Support  
Ranbaxy Laboratories Limited 
 
Primary Sponsor  
Name  Ranbaxy Laboratories Limited 
Address  Ranbaxy Laboratories Limited, Western Edge-1, Unit No. 201-204, 2nd Floor, Western Express Highway, Borivali (E), Mumbai – 400066. India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Aneja  Care and Cure  sec-7/d-15/57 and 61, rohini, delhi 85
New Delhi
DELHI 		 9811117266

drpankajaneja@sify.com 
Dr Anil Gupta  Dr Anil Gupta clinic  27, anand lok, august krantimarg new delhi 110049
New Delhi
DELHI 		 9871062888

dr.anilgupta27@gmail.com 
DR P CHINNAIYAN  DR P CHINNAIYAN clinic  43, PATEL ROAD, PERAMBUR, CHENNAI 600011
Chennai
TAMIL NADU 		 9444035399

drchinnaiyan@yahoo.com 
Dr Rohit S Baijal  Dr Rohit S Baijal clinic  3, narmada niwas, parmar guruji marg, parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9820298553

rsdbaijal@vsnl.net 
DR S MOORTHY  DR S MOORTHY clinic  NO 1, MOOSA STREET, T NAGAR CHENNAI 600017
Chennai
TAMIL NADU 		 9840116179

drsmoorthychennai@gmail.com 
Dr S P BYOTRA  Dr S P BYOTRA clinic  m-66, kirti nagar, new delhi 110015
New Delhi
DELHI 		 9811047379

byotra@yahoo.co.in 
dr Jagdish Gotur  dr.Bhagats polyclinic  ganjawalla bdg.II, 2nd floor, borivili (w) mumbai 400092
Mumbai
MAHARASHTRA 		 9892017519

drgotur@gmail.com 
DR R KEDARNATHAN   DR.R.KEDARNATHAN clinic  15, KARANEESWARAR KOIL STREET, FIRST LANE, MYLAPORE, CHENNAI 600004
Chennai
TAMIL NADU 		 9841640776

drkedar2011@rediffmail.com 
dr Subhash Sonawala  dr.sonalwala clinic  3/7, happy house, opp vakola market, santacruz (e) mumbai 400055
Mumbai
MAHARASHTRA 		 9821041280

subhashsonawala@hotmail.com 
Dr Chetan P Shah  heart rhythm clinic  3rd floor, manu mkt, next to kapol wadi, mg road, ghatkopar (w) mumbai 400086
Mumbai
MAHARASHTRA 		 9821115485

chetanshah@hotmail.com 
Dr Dayanand K Kumbla  JAY-ANAND HOSPITAL AND ICCU  MILDRED APTS. OPP-DAGDI SCHOOL NO.2, CHARAI, THANE WEST
Thane
MAHARASHTRA 		 25343814

kumbla@vsnl.com 
Dr Raman Abhi  Kanta Memorial Clinic  113/3 C-1, Silver Oaks, DLF city -I, Gurgaon
Gurgaon
HARYANA 		 9810077280

kmcraman@hotmail.com 
Dr Asha Moorthy  SRP CLINIC  8/26, Ranganatha Mudali Street C.Pallavaram
Chennai
TAMIL NADU 		 9884665004

drashasrmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CLINICOM, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  hyperlipidemia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rosuvastatin 10 mg arm  Rosuvas 10 mg oral, once daily, for 8 weeks 
Intervention  Rosuvastatin 20 mg arm  Rosuvas 20 mg oral, once daily, for 8 weeks 
Intervention  Rosuvastatin 5 mg arm  Rosuvas 5mg oral, once daily, for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female subject in the age range of 18-65 years.
2.Subjects with hyperlipidemia defined as fasting LDL cholesterol more than 130 mg/dL who require lipid altering therapy as judged by the treating physician.
3. Patients must be willing to follow the Therapeutic Lifestyle Changes (TLC) diet or similar cholesterol-lowering diet for the duration of the evaluation program.
4. Able to provide written, voluntary informed consent and have accessibility to the site.
5. Should not have received any statin/hypolipidemic therapy in the preceding 3 months at entry into the evaluation program.
 
 
ExclusionCriteria 
Details 
1.Female subject of child bearing potential or male subject who has a partner of childbearing potential, who refuses to use a medically acceptable form of contraception throughout the evaluation program.
2.Female subject who is pregnant or lactating.
3.Known hypersensitivity to Rosuvastatin or components
4.Active liver disease or hepatic dysfunction (defined by an ALT, AST concentration of greater than 1.5 times the upper limit of normal [ULN]),
5.Subjects with renal impairment or at screening presents with serum creatine greater than 1.4 mg/dL.
6.Serum CK concentrations of greater than 3 times the ULN
7.Usage of concomitant medications known to affect the lipid profile or present a potential safety concern (eg, through drug interaction)
8.Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the evaluation, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator;
9. Use of any investigational drug or participation of any clinical study within 30 days prior to this evaluation program.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage change from baseline in LDL-C for each dose group and average reduction across dose groups.

Percentage change from baseline in Total cholesterol, HDL-C and Triglycerides
 		 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of subjects achieving NCEP ATP III defined target levels in each dosage groups  8 weeks 
Incidence and type of any clinical or laboratory adverse experiences.   8 weeks 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   08/08/2011 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a prospective, open-label, multi-center, post-marketing evaluation program to evaluate the lipid-altering efficacy and safety of Rosuvastatin in hyperlipidemia patients in routine clinical practice. Six hundred (600) patients who meet the entry criteria will be allocated to the rosuvastatin start dose of 5mg, 10 mg or 20 mg based on the treating physician judgment considering the baseline LDL-Cholesterol levels, future cardiovascular risk, potential risk for adverse reactions, and recommendations in the package insert (label).

 

Rosuvastatin at the chosen dose level will be administered once daily for a total duration of 8 weeks and lipid levels and safety and tolerability will be measured on completion of 4 weeks and 8 weeks of therapy.

 
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