| CTRI Number |
CTRI/2010/091/001437 [Registered on: 12/11/2010] |
| Last Modified On: |
05/09/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA?. |
|
Scientific Title of Study
|
"A CONTROL LABELED, RANDOMIZED, COMPARATIVE, PARALLEL GROUP, MULTICENTRIC PHASE III STUDY TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA". |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/AL/CT-III-1568/11-09 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Bhambe |
| Designation |
|
| Affiliation |
|
| Address |
Opposite to Nathu sweets
Laxmi Nagar
New Delhi
DELHI
110 092
India |
| Phone |
09654807949 |
| Fax |
|
| Email |
drdeepakbhambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
|
| Affiliation |
Nexus Clinical Research (India) Ltd |
| Address |
Anuj, Plot No. 45, Ist Floor,
Mumbai-Pune Highway, Near D. Y. Patil Stadium, Sector-13, Nerul (E),
Mumbai
MAHARASHTRA
400 706
India |
| Phone |
+91-22-27714204 |
| Fax |
ext 108 |
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhatt |
| Designation |
|
| Affiliation |
|
| Address |
Anuj, Plot No. 45, Ist Floor,
Mumbai-Pune Highway, Near D. Y. Patil Stadium, Sector-13, Nerul (E),
Mumbai
MAHARASHTRA
400 706
India |
| Phone |
+91-22-27714204 |
| Fax |
ext 108 |
| Email |
dramit.bhatt@gmail.com |
|
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Source of Monetary or Material Support
|
| Alembic Ltd
3rd Floor, Alembic Road,
Baroda - Gujarat ,
INDIA 390003
|
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Primary Sponsor
Modification(s)
|
| Name |
CJSC RCI Syntez |
| Address |
Office: 2H-11H, House 7 lit. A, Torfyanaya doroga, Saint Petersburg, Russia, 197374 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. TANURAJ SIROHI |
Hope Hospital |
W.K road ,Chippi Tank -250001
Meerut
UTTAR PRADESH |
09837052678
NIL
trsirohi@yahoo.com |
| DR. KISHOR KADU |
Jeevandeep Hospital |
Rajendra Colony,Prashant Nagar Road-444606
Amravati
MAHARASHTRA |
09822590918
NIL
NIL |
| DR. SHRIRAM V.KULKARNI |
Kharghar Diabetes And Heart Care Centre |
Shri Balagi Krupa, Plot 19 A,Sector-20-410210
|
09422493926
NIL
drsvk123@rediffmail.com |
| DR. K.MOHAN PAI |
Mangalore Heart Centre |
No. 8, City Point,Kodialbail-575003
Bangalore
KARNATAKA |
09854083135
NIL
mahanpaik@rediffmail.com |
| DR. DEEPAK BHAMBE |
Narendra Prakash Health Care Centre, |
Opposite to Nathu sweets,Laxmi Nagar-110 092
New Delhi
DELHI |
09654807949
NIL
drdeepakbhambe@gmail.com |
| DR. SATISH KUMAR GUPTA |
Somdatt Poly Clinic |
S-524, School Block , Laxmi Nagar-110 092
New Delhi
DELHI |
09811212494
NIL
kumar6511@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg |
ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg for 12 weeks |
| Comparator Agent |
ROSUVASTATIN |
5mg for 12 weeks |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Subjects of either sex of age 18 and 70 years.
Low-density lipoprotein (LDL)-cholesterol levels > 100 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.
Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Hypersensitivity to either of the formulation components.
Severe renal dysfunction.
Hepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality.
Pre-existing gallbladder disease.
x Subjects with a history of known hypersensitivity from any one of the said medication.
Pregnant women or lactating woman.
Participation in a clinical trial with an investigational agent during the past 30 days.
Simultaneous participation in a clinical study.
Severe uncontrolled systemic disease. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in low density lipoprotein cholesterol after 12 weeks. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks.
Number of patients who reach target LDL after 12 weeks.
|
12 weeks |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
20/09/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs), and laboratory tests {Fasting Serum Lipid Profile, Liver function tests (SGOT, SGPT, Serum Bilirubin), Renal Function Tests (Serum Creatinine, and Serum Uric Acid). Blood sample will be collected for laboratory evaluations during screening. Female volunteers of child bearing capability will be subjected to a urine pregnancy test. The subject would be randomized in two parallel arm and according to the randomization done they would be assigned for the treatment for either of the arm FDC of Rosuvastatin and Fenofibrate ,or monotherapy of Rosuvastatin Calcium |