| CTRI Number |
CTRI/2011/091/000030 [Registered on: 07/01/2011] |
| Last Modified On: |
15/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
To determine the efficacy and safety of a combination of Extended Release (ER) Niacin and Rosuvastatin as compared with Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia. |
Scientific Title of Study
Modification(s)
|
A randomized, double blind, comparative, multicentric study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President, Medical Services |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President, Medical Services |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
Vice President, Medical Services |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Troikaa Pharmaceuticals Ltd.,
Commerce House-1, Opp Rajvansh Tower
Off. Judges Bunglows, Ahmedabad 380054 |
|
Primary Sponsor
Modification(s)
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Commerce House-I, Opp. Rajvansh Appt., Satya Marg, Bodakdev, Ahmedabad - 380054 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish C Rajadhyaksha |
B.Y.L. Nair ch. Hospital & T. N. Medical College |
Dr. A. L. Nair Road,-400008
Mumbai
MAHARASHTRA |
9821695349
girishraj63@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, B.Y.L. Nair ch. Hospital & T. N. Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Mixed Dyslipidemia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Matching Placebo + Rosuvastatin Tablet |
At the beginning of the study all patients receives one tablet of Matching placebo once a day. Dose of Placebo will be gradually titrated to three tablets over a period of 4 week. Rosuvastatin will be given in dose of 5 mg/day. |
| Intervention |
Niacin 500 mg Extended Release tablet + Rosuvastatin Tablet |
At the beginning of the study all patients receives 500mg of Extended Release Niacin once a day. Dose of Niacin will be gradually titrated to 1500mg over a period of 4 week. Rosuvastatin will be given in dose of 5 mg/day. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 18-75 years suffering from Mixed dyslipidemia
2.Patients with LDL-C level > 130 mg/dL
3.Patients with HDL-C level < 40 mg/dL
4.Patients requiring Rosuvastatin therapy (already receiving Rosuvastatin or recently started) |
|
| ExclusionCriteria |
| Details |
1.Patient with history of hypersensitivity to any statin, niacin or aspirin
2.Patients with uncontrolled diabetes
3.Patients with clinically unacceptable laboratory parameters
4.Patients with peptic ulcer disease
5.Patients with history of bleeding or coagulation disorder
6.Patients requiring hospitalization
7.Patient with history of hypotension
8.Patients with compromised hepatic and renal function
9.Pregnant and lactating women
10.Women of child bearing age not practicing or not willing to use contraceptive
11.Patients experiencing post menopausal hot flashes
12.Mentally retarded patients
13.Patients not willing to sign written informed consent
14.Patients receiving hormone replacement therapy, high dose of antioxidant vitamin therapy or systemic corticosteroid therapy
15.Patients requiring concomitant therapy with other lipid lowering drugs
16.Patients who participated in clinical trial with in 30 days before enrollment into the study
17.Patients, for any reason who are considered to be unsuitable candidates by the investigator. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in lipid profile (TC, LDL-C, HDL-C and TG) |
Baseline Visit, 3rd Visit & End of Study Visit |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Drop out rate because of flushing |
During entire Study Period |
| Median time for flushing |
During Entire Study Period |
| Median duration of flushing |
During Entire Study Period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
17/01/2011 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
There is no publication from this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, comparative study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia. All patients will be randomly divided in two Groups. Patient will be received either Niacin and rosuvastatin or matching Placebo and Rosuvastatin according to randomization number. Change in lipid profile will be measured at various time points. Primary outcomes like Incidence and Severity of Flushing will be measured during the conduct of study. |