| CTRI Number |
CTRI/2023/09/057954 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
EMR study |
| Study Design |
Other |
|
Public Title of Study
|
Retrospective Study to assess the Prevalence and Treatment of Dyslipidemia in Indian Patients |
|
Scientific Title of Study
|
Retrospective Observational EMR based Real World Study to assess the Prevalence and Treatment
of Dyslipidemia in Indian Patients
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-038-DYSL/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Rathod |
| Designation |
Trial coordinator |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
9987246597 |
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Mujtaba Hussain Naqvi |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
7032969523 |
| Fax |
|
| Email |
mujtabanaqvi@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
9987246597 |
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Jay Shah |
Healthplix Technologies |
1st floor, AWFIS, Vajram Esteva New survey No 57/4. Old survey No. 57/2, Marathahalli-Sarjapur, Bengaluru, Karnataka-560103
Bangalore
KARNATAKA |
9898209755
jayshah08@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Dyslipidemia patients |
|
| ExclusionCriteria |
| Details |
Patients not diagnosed with dyslipidemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of dyslipidemia.
Incidence of newly diagnosed dyslipidemia. |
A follow-up data will be captured at 3 months ±30 days from the baseline visit/index date per patient to assess the change in lipid levels over time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Levels of TC, LDL, HDL, VLDL, & serum TG in newly diagnosed dyslipidemia patients with different concurrent conditions at baseline & follow-up. Number & percentage of newly diagnosed dyslipidemia
patients achieving target LDL levels according to international guidelines
and LAI consensus statement. |
Outcome analysis will be done for the patients who have a follow up visit within 10-30 days from prescription of amlodipine or its combinations. |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective Observational EMR based Real World Study to assess the Prevalence and Treatment of Dyslipidemia in Indian Patients.
Dyslipidemia is closely associated with coronary artery disease (CAD), and type-2 diabetes mellitus. Early detection of dyslipidemia through laboratory tests can prevent or help in reducing CAD, and indeed all-cause mortality. As the prevalence of dyslipidemia is high in developing countries like India, awareness of dyslipidemia is essential.
This study is planned to collect data of Indian patients with dyslipidemia through EMR which helps physicians to understand current prevalence of dyslipidemia and comorbidities in dyslipidemia patients and treatment pattern. |