| CTRI Number |
CTRI/2018/04/013453 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of two drugs Telmisartan and Cilnidipine in patients with high blood pressure and heart disease |
|
Scientific Title of Study
|
Efficacy, Safety and Cost effectiveness of Telmisartan and Cilnidipine in Hypertensive Patients with coronary artery disease in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Althab Begum |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital RC |
| Address |
SRM Medical College Hospital and Research Institute
Potheri Kattankulathur
Kancheepuram District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884272226 |
| Fax |
|
| Email |
dralthab24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajit Mohapatra |
| Designation |
Associate Professor of Pharmacology |
| Affiliation |
SRM Medical College Hospital RC |
| Address |
SRM Medical College Hospital and Research Institute
Potheri Kattankulathur
Kancheepuram District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9791161626 |
| Fax |
|
| Email |
satyajitmp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajit Mohapatra |
| Designation |
Associate Professor of Pharmacology |
| Affiliation |
SRM Medical College Hospital RC |
| Address |
SRM Medical College Hospital and Research Institute
Potheri Kattankulathur
Kancheepuram District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9791161626 |
| Fax |
|
| Email |
satyajitmp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology,
SRM MCH & RC |
|
|
Primary Sponsor
|
| Name |
SRM |
| Address |
SRM MEDICAL COLLEGE AND HOSPITAL RC |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Althab Begum |
SRM Medical College & Hospital & Research Center |
Department of Cardiology
Potheri, Kattankulathur
603203
Kancheepuram
TAMIL NADU |
9884272226
dralthab24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients known case of Hypertensives with Coronary artery disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients 18-80 years of age.
2.Known hypertensive patients with coronary artery
disease
3.Range of blood pressure in >140/90mmHg
4.Hypertensive patients with co morbidity conditions like Diabetes mellitus, Dyslipidemia
|
|
| ExclusionCriteria |
| Details |
1.Age below 18 years and above 80 years
2.Pregnant and lactating women.
3.Patients with hepatic impairment.
4.Patients with acute illness or blood pressure >180mmHg systolic or >120mmHg diastolic
5.Known hypersensitivity to telmisartan/cilnidipine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective is to evaluate the SBP and DBP as compared to baseline of telmisartan and Cilnidipine |
The blood pressure readings will be noted on Day 0, 4 weeks, 12 weeks and the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the parameters between two groups in hypertensive patients. Samples are collected from patients and tested for Blood urea and Serum Creatinine, Sodium, Potassium, Chloride and Bicarbonate.
|
The samples are collected on Day 0 and the end of 6 months. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/10/2016 |
| Date of Study Completion (India) |
05/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
It will be published in peer reviewed journal by this year end |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is the major risk factor for cardiovascular mortality. One of the important elements in hypertension control is early diagnosis. Reduction in blood pressure by 5mmHg can decrease the risk of Stroke by 34%, Ischemic Heart Disease by 21% reduce dementia, heart failure and mortality from Cardiovascular
disease. Telmisartan is a long acting Angiotensin Receptor Blocker (ARB), which has affinity for AT1 receptors. The pharmacokinetic of Telmisartan is having a long
half life of 24 hours, good penetration due to large volume of distribution and minimal renal clearance compared to other ARB’s. Cilnidipine is an intermediate acting
dihydropyridine. It is given in patients with isolated systolic hypertension and is renoprotective. Hence this study is taken to evaluate the efficacy and safety of
Telmisartan and Cilnidipine in hypertensive patients with Coronary Artery Disease. Blood pressure is decreased significantly in both the groups and there was decrease
in heart rate in patients taking Cilnidipine. The pharmacoeconomic factors will be taken into consideration to derive a cost effective regime, so that patients can
continue the medications for a long term for better therapeutic outcome.
|