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CTRI Number  CTRI/2011/05/001761 [Registered on: 26/05/2011] Trial Registered Retrospectively
Last Modified On: 02/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia 
Scientific Title of Study   Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia (A Randomized, Double-blind, Parallel-group, Active-comparator Controlled, Phase II Clinical Study)  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
CR – 09/ 5024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhaumik Mody 
Designation  Manager 
Affiliation  Principal Investigator 
Address  Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dholka-387810
A/802, Royal Chinmay Tower Opp IOC petrol pump Besdie Platinum Plaza Off Judges Bunglow Road Bodakdev, Ahmedabad-380054
Ahmadabad
GUJARAT
380054
India 
Phone  9825060463  
Fax    
Email  bhaumik.mody@cadilapharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhaumik Mody 
Designation  Manager 
Affiliation  Principal Investigator 
Address  Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dholka-387810
A/802, Royal Chinmay Tower Opp IOC petrol pump Besdie Platinum Plaza Off Judges Bunglow Road Bodakdev, Ahmedabad-380054

GUJARAT
380054
India 
Phone  9825060463  
Fax    
Email  bhaumik.mody@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhaumik Mody 
Designation  Manager 
Affiliation  Principal Investigator 
Address  Cadila Pharmaceuticals Ltd. 1389, Trasad Road, Dholka-387810
A/802, Royal Chinmay Tower Opp IOC petrol pump Besdie Platinum Plaza Off Judges Bunglow Road Bodakdev, Ahmedabad-380054

GUJARAT
380054
India 
Phone  9825060463  
Fax    
Email  bhaumik.mody@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Ltd 
Address  1389, Trasad Road, Dholka-387810 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhaumik Mody  Cadila CRO  Research & Development, CRO division Cadila Pharmaceuticals Ltd., Dholka-387810 Contact No: 02714-221481 Ext: 180
Ahmadabad
GUJARAT 		 02714-221481

bhaumik.mody@cadilapharma.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethique  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hyperlipidaemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CDRI 80/574 + Atorvastatin  Dose: CDRI 80/574 50/100/200 mg + Atorvastatin 10 mg Duration: once daily for 2 wks Route of administration: Oral  
Comparator Agent  Placebo + Atorvastatin  Dose: matching placebo of CDRI 80/574 + Atorvastatin 10 mg Duration: once daily for 2 wks Route of administration: Oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy volunteers
2. 18-45 years of age
3. Either sex
4. Willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity or intolerance to the study drugs
2. Pregnant or lactating women
3. HIV positive subjects
4. Presence of liver disease: Serum bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 times the upper limit of normal (ULN)
5. Presence of kidney disease: Serum Creatinine 1.5 times the ULN
6. Subjects with abnormal hematologic function (Hemoglobin ¡Ü 8gm/dl, WBC count ¡Ü3000/mm3, platelet count ¡Ü100,000/mm3).
7. Presence of systemic diseases such as seizure disorder, diabetes mellitus, congestive heart failure or malignancy
8. Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy will be excluded.
9. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
10. Resting heart rate of 100 beats/min or 60 beats/min on the screening day.
11. History of hypotensive episodes, or systolic blood pressure reading of 100 mm Hg or a diastolic reading of 60 mm Hg at time of general physical examination.
12. History of hypertension, or systolic blood pressure reading of 139 mm Hg or a diastolic reading 89 mm Hg at time of general physical examination.
13. Subject who have taken over the counter or prescribed medications, including any enzymes modifying drugs or any systemic medication within the past four weeks prior to start of clinical period.
14. Subjects receiving lipid-lowering therapy during 4 weeks preceding enrollment
15. Chronic alcoholic or drug abuse subjects
16. Heavy smokers (smoking 10 cigarettes/biddies/day) or mild to moderate smokers (smoking 10 cigarettes/biddies/day) who are not willing to discontinue smoking 48 hours before initiation of study and during the study period.
17. Subject who participated in any other clinical investigation using an experimental drug or have donated blood or had more than 300ml of blood drawn in the past 3 months.
18. Subject without adequate venous access to allow collection of all samples via venous cannula during the study.
19. Subjects unwilling or unable to comply with the study procedures.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
change in LDL-C, triglycerides and HDL-C from baseline to study close out  change in LDL-C, triglycerides and HDL-C from baseline to study close out 
 
Secondary Outcome  
Outcome  TimePoints 
percentage change in other lipid parameters, including total cholesterol, apo B and apo A-1 from baseline to study close out and rate of dropouts due to treatment related adverse events  percentage change in other lipid parameters, including total cholesterol, apo B and apo A-1 from baseline to study close out and rate of dropouts due to treatment related adverse events 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 2 
Date of First Enrollment (India)   13/05/2011 
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="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia
 (A Randomized, Double-blind, Parallel-group,
Active-comparator Controlled, Phase II Clinical Study)  
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