| CTRI Number |
CTRI/2010/091/003056 [Registered on: 15/12/2010] |
| Last Modified On: |
02/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Multicenter, Randomized, Parallel-Group Study to compare the efficacy of three strenghts of FDC containing rosuvastatin and micronized fenofibrate on lipid profile in patients with mixed dyslipidemia. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Parallel-Group, Open label Study to compare the efficacy of three strenghts of FDC containing rosuvastatin and micronized fenofibrate on lipid profile in patients with mixed dyslipidemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
|
|
Primary Sponsor
|
| Name |
Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032. |
|
| TAAB Biostudy Services, 27, Central Road, Jadavpur, Kolkata-700032 |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Balaram Ghosh |
Bankura Sammilani Medical College |
Bankura Sammilani Medical College ,Govt. of W. B., Bankura , -
Bankura
WEST BENGAL |
09433412788
drbrghosh@gmail.com |
| Dr. Arunava Biswas |
Calcutta National Medical College |
Calcutta National Medical College,,-
|
09674328329
drabiswas@gmail.com |
| Dr. T. K. Chattaraj |
Dafodil Nursing Home Pvt. Ltd. |
Dafodil Nursing Home Pvt. Ltd.,276 Canal Street-700048
Kolkata
WEST BENGAL |
(033) 25346649/5681, Mobile: 09831070050
asmi_1234@rediffmail.com |
| Dr. R. G. Bhagat |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik |
Dr. Bhagat's Allergy- Asthma Clinic And Respiratory Care Centre, Pathik, ,Dashaporwad Society , Gajarawala Flats Lane, B/h. Paldi Bus Stand, Paldi , -380007
Ahmadabad
GUJARAT |
(079) 26574746
rajpurvi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. Arunava Biswas) |
Approved |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. Balaram Ghosh) |
Approved |
| COMSARTS (IEC) Committee for Safety & Rights of Trial Subjects (Dr. R. G. Bhagat) |
Approved |
| Institutional Ethics Committee, Jadavpur University (Dr. T. K. Chattaraj) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Mixed dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC 1- Rosuvastatin 5 mg+Fenofibrate 160 mg, |
OD for 12 weeks |
| Intervention |
FDC 2-Rosuvastatin 10 mg+Fenofibrate 160 mg, |
OD for 12 weeks |
| Intervention |
FDC 3-Rosuvastatin 20 mg+Fenofibrate 160 mg |
OD for 12 weeks |
| Comparator Agent |
Fenofibrate monotherapy (160 mg) 2 |
OD for 12 weeks |
| Comparator Agent |
Rosuvastatin monotherapy (5mg, 10mg, & 20mg) |
OD for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients in the age group of 20-80 years
2. Subjects willing to give informed consent.
3. Patients with mixed dyslipidemia. The patients can be anti-lipid drug therapy naïve patients as well Statin treated patients.
4. Patients who were willing to comply with all study requirements
|
|
| ExclusionCriteria |
| Details |
1. Subjects who were currently participating or had participated in other interventional study the last 3 months prior to their enrolment.
2. Women who were pregnant, breast feeding or had the intention of becoming pregnant during their participation in the study.
3. Women of childbearing potential who were not using effective and medically acceptable methods of contraception.
4. Subjects who were meeting any of the contraindications of the study medication according to the approved SPC.
5. Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout.
6. Patients with diabetes will be included in the study if they are adequately controlled (HbA1c<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
7. Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
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 trial, 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 trial within 30 days prior to this study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change from baseline in LDL-C for Biocon`s FDC Rosuvastatin and Fenofibrate vs. Rosuvastatin monotherapy and fibrate monotherapy after 3 months of treatment. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The percentage of patients reaching the LDL-C target levels as per the NCEP ATP III Guideline at the end of 3 months treatment in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy. |
3 months |
| To compare the safety and tolerability of FDC by observing adverse events, changes in laboratory safety variables and discontinuations in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy |
3 months |
| To compare the percentage change in HDL-C, total cholesterol (TC) and fasting triglycerides (TG) levels from the baseline to end of 3 months therapy with Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy. |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="160"
Sample Size from India="160"
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) |
19/11/2010 |
| 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Multicenter, Randomized, Parallel-Group Study to compare the efficacy of three strenghts of FDC containing rosuvastatin and micronized fenofibrate on lipid profile in patients with mixed dyslipidemia. This study will be conducted at four centers in India. Percentage change from baseline in LDL-C will be regarded as the primary outcome of the study.
|