| CTRI Number |
CTRI/2018/08/015417 [Registered on: 23/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the efficacy and tolerability of Rosuvastatin, in the Indian patients, with Dyslipidemia |
|
Scientific Title of Study
|
An open labeled, non-randomised, non - comparative, multicentric Post Marketing Study on the efficacy and tolerability of Rosuvastatin, in the Indian patients, with Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLL/RID/05/2016 dated 12 May 2016 version 1.00 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Suresh |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
Dept of Medical Services, Room No 1, 1st Floor #27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Suresh |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
Dept of Medical Services, Room No 1, 1st Floor #27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
27, Race Course Road, Bangalore |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
Dept of Medical Services, Room No 1, 1st Floor #27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited, 27, Race Course Road, Bangalore |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
27, Race Course Road, Bangalore |
| 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 Sunil Sathe |
Cardiac Care And Counselling Center |
Cardiac Care And Counselling Center, Park Plaza, Opposite
Kamla Nehru Park, Off, Bhandarkar Rd, 411004
Pune
MAHARASHTRA |
9822030125
svscardcare@gmail.com |
| Dr Nitin S Gokhale |
Dr. Gokhales Clinic |
104, Mamta House, Above IndusInd Bank, S V Road
Mumbai
MAHARASHTRA |
9821034606
skm8587@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bangalore Ethics |
Approved |
| Bangalore Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Rosuvastatin |
Participants will be administrated with Rosuvastatin 5/1O/20/40 mg tablet orally once daily for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. LDL-C levels of> 130 mg/dland < 250 mg/dl
2. TG levels of <500 mg/dl
3. Willing to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women
2. Hypersensitivity to rosuvastatin
3. Other concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3 fatty acids
4. LDL-C > 250 mg/dL,Triglyceride level >500 mg/dl
5. Participation in another investigational drug trial within 4 weeks of trial enrollment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent reduction in the subjects with optimal values of LDL-C [ 100 mg/dl] at the end of the treatment |
baseline, 12 , 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of 24 weeks therapy with 5 mg/1O mg/20 mg/40 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C and Non-HDL-C |
24 Weeks |
| Assess the safety of rosuvastatin by analyzing the adverse events reported and evaluated by the treating physician |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="4000"
Sample Size from India="4000"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/06/2016 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Purpose of this study is to assess the efficacy of Rosuvastatin, 1O mg) once daily, by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of < 100 mg/dl after 24 weeks of therapy |