| CTRI Number |
CTRI/2010/091/000147 [Registered on: 25/03/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia |
|
Scientific Title of Study
|
A multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the safety and efficacy of Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/Raven_RosuFen/0909A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Dr. R.N. Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Dr. R.N. Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Dr. R.N. Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
|
Source of Monetary or Material Support
|
| M/s. Ravenbhel Healthcare Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
M/s. Ravenbhel Healthcare Pvt. Ltd. |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
Clinic, Bhavnagar, Rajivoza59@hotmail.com,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr. Nitin m Rathod |
Dr. R.N.Cooper Hospital, Vileparle west,Mumbai,nitinmr@yahoo.in |
R.N. Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in,-400057
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
| Dr. Kirti C Patel |
K E M Hospital, Mumbai, pkirtic@yaahoo.in |
K E M Hospital, Mumbai , pkirtic@yahoo.in,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr. Raj G Bhagat |
Smt. N H L Muni. medical college Ahmedabad, Rajpurvi@yahoo.com |
Smt. N H L Muni. medical college Ahmedabad, Rajpurvi@yahoo.com,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Rosuvastatin and Fenofibrate |
5mg and 160 mg, once daily |
| Comparator Agent |
Rosuvastatin |
5mg , once daily |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Male and female outpatients between 18-75 tears of age.
Patients having i. LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl.
Able to stop current statin therapy without risk to the patient
Patients who are able to adequately maintain diary.
Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF |
|
| ExclusionCriteria |
| Details |
No willing to sign ICF, Hypersensitivity to statins, Serum triglyceride levels > 500mg/dl.Patients with hepatic disease, poorly controlled diabetes mellitus, patients familiar with muscular pain, myopathy.Stroke less than six months prior to informed consent. pregnancy and lactation, history of pancreatitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change from baseline values of LDL-C, serum triglycerides, HDL-C |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Achievement of target levels of total cholesterolnd LDL cholesterol, patient compliance |
|
|
|
Target Sample Size
|
Total Sample Size="200"
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) |
06/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
This study is a multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the efficacy and safety of FDC of tablets of Rosuvastatin 5 mg and Telmisartan 160 mg with Rosuvastatin 5mg alone in patients with dyslipidemia in 200 patients will be conducted in 4 centres in India |