| CTRI Number |
CTRI/2011/091/000057 [Registered on: 01/02/2011] |
| Last Modified On: |
15/02/2013 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
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A Clinical Study to Evaluate the Safety and efficacy of fixed dose combination containing rosuvastatin calcium with ezetimibe versus monotherapy in dyslipidemic patients |
Scientific Title of Study
Modification(s)
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A multicentre, comparative, controlled, open label, randomized, parallel-group, phase III study to evaluate the safety and efficacy of fixed dose combination containing rosuvastatin calcium with ezetimibe versus monotherapy in dyslipidemic patients |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| G7SYN/P-002/2010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balaji Karthikeyan |
| Designation |
|
| Affiliation |
|
| Address |
G7 Synergon Private Limited. No 537, 9th Cross, 5th Main, Tatanagar, Sahakaranagar Post
Sahakarnagar, behind big bazaar, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
080-22172700 |
| Fax |
080-22172777 |
| Email |
regulatory@g7synergon.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vanita Sabhahit |
| Designation |
|
| Affiliation |
|
| Address |
Biocon Ltd. 20th km., Hosur Road
Electronics City P.O.
Bangalore
KARNATAKA
560092
India |
| Phone |
080-2808 7513 |
| Fax |
080-2852 3423 |
| Email |
vanita.sabhahit@biocon.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vanita Sabhahit |
| Designation |
|
| Affiliation |
|
| Address |
Biocon Ltd. 20th km., Hosur Road
Electronics City P.O.
Bangalore
KARNATAKA
560092
India |
| Phone |
080-2808 7513 |
| Fax |
080-2852 3423 |
| Email |
vanita.sabhahit@biocon.com |
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Source of Monetary or Material Support
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Primary Sponsor
Modification(s)
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| Name |
Biocon Ltd |
| Address |
Biocon Ltd. 20th km., Hosur Road, Electronics City P.O. Bangalore-560092 Karnataka |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Noor Khan |
Indian Diabetic & Heart Centre |
Behind Forrest Office Gangamma temple Road,M.V. Extension, Hoskote-562114
Bangalore
KARNATAKA |
080-27932215
noorkhandr@gmail.com |
| Dr. G.M. Prasad |
Parnav Diabetes Centre |
No. 53, Nanda Complex,Ramamurthy Nagar Main Road, Banaswadi-560043
Bangalore
KARNATAKA |
080- 22744035
drgmprasad@gmail.com |
| Dr. Manohar Kathige Nageshappa |
R.K. Hospital |
31, Kammanahalli Main Road,St. Thomas Town Post-560084
Bangalore
KARNATAKA |
080-25801999
drmanohar-kn@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Clinicom |
Approved |
| Clinicom |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination (FDC) containing Rosuvastatin calcium with Ezetimibe |
Rosuvastatin calcium 5/10/20 mg/day + Ezetimibe 10/10/10 mg/day |
| Comparator Agent |
Monotherapy (Rosuvastatin calcium or Ezetimibe) |
Rosuvastatincalcium 10 mg/day or Ezetimibe 10mg/day |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
?Male and female patients with hyper LDL cholesterolemia, aged 20-80 years (both years inclusive)
?Patients with LDL-C >=160 mg/dL and <250 mg/dL on fasting conditions
?Patients with hypercholesterolemia (with Non-HDL-C) who are above target goal according to NCEP-ATP III after 3 months of treatment with other conventional statin doses, e.g. simvastatin 10-40 mg.
?Patients who are willing to comply with all study requirements
?Females of childbearing potential should have a negative pregnancy test at the prestudy visit and agree to use contraception during the study
?Patients willing to give informed consent
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| ExclusionCriteria |
| Details |
?Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
?Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
?Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
?Women of childbearing potential who are not using effective and medically acceptable methods of contraception.
?Patients who are meeting any of the contraindications of the study medication according to the approved Summary of Product Characteristics (SPC).
?Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism, liver disease (SGOT and/or SGPT 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.
?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).
?Patients who are positive for HIV test
?Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded
?Patients currently undertaking drugs like Cyclosporine, Niacin, Fenofibrate, Gemfibrozil, Lopinavir (or other protease inhibitors) Coumarin anticoagulants, clarithromycin, erythromycin, ketoconazole and itraconazole
?Patients with abnormal Creatine kinase (CK) level
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Method of Generating Random Sequence
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Stratified randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Percentage changes from baseline levels of LDL-C with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy with rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of therapy |
4 weeks treatment |
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Secondary Outcome
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| Outcome |
TimePoints |
| The percentage change in HDL-C, TC and fasting TG levels from the therapy initiation (baseline values) to the levels at the end of 4 weeks of the study. |
4 Weeks treatment |
| The percentage of patients treated with FDC of rosuvastatin calcium (20/10/5 mg) with ezetimibe 10 mg vs. monotherapy of these drugs achieving LDL-C levels recommended by NCEP/ATP III, after 4 weeks of therapy. |
4 Weeks treatment |
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Target Sample Size
Modification(s)
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Total Sample Size="0"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
02/02/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a multicentric, comparative, open label, randomized, parallel-group, phase III study. The primary objective is to asses and compare the LDL-C lowering efficacy of fixed dose combinations of rosuvastatin calcium (5/10/20 mg) and ezetimibe 10 mg in comparison with rosuvastatin calcium10 mg or ezetimibe 10 mg, monotherapy, after 4 Weeks of treatment. Secondary objective would be to assess and compare the effects of FDC of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy of these drugs on percentage change in HDL-C, TC, TG, non-HDL-C, TC/HDL-C, LDL-C/HDL-C and nonHDL-C/HDL-C from baseline after 4 weeks of therapy and also to assess the safety and tolerability of FDC of rosuvastatin calcium (5/10/20 mg) in combination with ezetimibe 10 mg vs. rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of treatment. This study is sponsored by Biocon with three centers across india. The study will recruit 200 patients from India. |