| CTRI Number |
CTRI/2010/091/001328 [Registered on: 17/09/2010] |
| Last Modified On: |
10/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Daily Vs Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the Efficacy and Safety of Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DR N HARIVENKATESH |
| Designation |
|
| Affiliation |
|
| Address |
DEPT. OF PHARMACOLOGY
SRI RAMACHANDRA MEDICAL COLLEGE & RESEARCH INSTITUTE, PORUR
Chennai
TAMIL NADU
600023
India |
| Phone |
044-24768403 |
| Fax |
|
| Email |
dr_harivenkatesh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. N. HARIVENKATESH |
| Designation |
|
| Affiliation |
SRI RAMACHANDRA UNIVERSITY |
| Address |
DEPT. OF PHARMACOLOGY
SRI RAMACHANDRA MEDICAL COLLEGE & RESEARCH INSTITUTE, PORUR
Chennai
TAMIL NADU
600023
India |
| Phone |
044-24768403 Extn 225 |
| Fax |
|
| Email |
dr_harivenkatesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR. N. HARIVENKATESH |
| Designation |
|
| Affiliation |
|
| Address |
DEPT. OF PHARMACOLOGY
SRI RAMACHANDRA MEDICAL COLLEGE & RESEARCH INSTITUTE, PORUR
Chennai
TAMIL NADU
600023
India |
| Phone |
044-24768403 Extn 225 |
| Fax |
|
| Email |
dr_harivenkatesh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
NIL Investigator Initiated Trial |
| Address |
NIL |
| Type of Sponsor |
Other [Investigator Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. N. Hari Venkatesh |
Dept. of Internal Medicine & Dept. of Cardiology, Sri Ramachandra Medical College Hospital, Porur, Chennai-600116 |
,-600116
Chennai
TAMIL NADU |
044-24768403 Extn 225
dr_harivenkatesh@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee (for students proposals), Sri Ramachandra University, Chennai-600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Mixed Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed Dose Combination of Atorvastatin 10mg & Fenofibrate 160mg |
One Tablet to be taken at night DAILY for 12 Weeks |
| Intervention |
Fixed Dose Combination of Atorvastatin 10mg & Fenofibrate 160mg |
One Tablet to be taken at night on ALTERNATE DAYS for 12 Weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1) Adult Male and Female patients of age >18years and <= 65years who are diagnosed as Mixed Dyslipidemia and meet the criteria for pharmacological treatment as per updated NCEP-ATP III guidelines 2) Fasting LDL levels >= 130mg/dL, Fasting TGL levels >= 200mg/dL, Fasting Total Cholesterol levels >= 200mg/dL 3) Patients who failed to achieve lipid target goals as per updated NCEP-ATP III guidelines with Therapeutic life style changes or with other modalities of treatment 4) Eligible patients who are willing to participate in the study by voluntarily signing the Informed Consent Form
|
|
| ExclusionCriteria |
| Details |
1) Patients who are already on treatment with statins or fibrates. 2) Patients allergic/hypersensitive to either Atorvastatin or Fenofibrate. 3) Pregnant and Lactating women. 4) Women of child bearing age not using acceptable methods of contraception. 5) Patients with active liver disease having elevated liver enzymes. 6) Patients with Uncontrolled Diabetes Mellitus with FBS>200mg/dL even after therapy with OHA/Insulin. 7) Patients with elevated Creatine Kinase levels /muscular disorders. 8) Post-MI, Post-CABG, Post-PTCA, Post-Stroke patients within six months of occurrence of the event. 9) CCF patients receiving Digoxin. 10) Patients unwilling to give informed consent. 11) Mentally challenged patients who are unable to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy. |
0, 6weeks, 12weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1) Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy. 2)Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy. 3)Pharmacoeconomic evaluation in both groups. |
0, 6weeks, 12weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Randomized, open labeled, parallel group, single centre study to evaluate the efficacy and safety of Alternate day therapy with Atorvastatin and Fenofibrate combination in comparison with Daily therapy in the treatment of Mixed Dyslipidemia. 110 patients diagnosed with Mixed Dyslipidemia requiring pharmacological treatment as per Updated NCEP-ATP III guidelines will be enrolled in the study. (55 study participants in each group). Only the patients satisfying the eligibility criteria and willing to participate in the study by voluntarily signing the informed consent form will be included in the study. The study drug is Fixed Dose Combination of Atorvastatin 10mg and Fenofibrate 160mg.The participants in the interventional group will receive the study drug on Alternate days for 12weeks. The study participants in the control group will receive the study drug daily for 12weeks. The primary endpoint is the percent change in TGL and non-HDL levels from baseline to 12weeks of therapy. The secondary endpoints are Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy, Pharmacoeconomic evaluation in both groups. The safety endpoints are Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy. |