| CTRI Number |
CTRI/2017/09/009725 [Registered on: 12/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of blood pressure lowering effect of drugs. |
|
Scientific Title of Study
|
To compare the antihypertensive effect of Fixed dose drug combination Telmisartan and Amlodipine versus Telmisartan and Amlodipine given individually in hypertensive patients - a randomized controlled study. |
| Trial Acronym |
Anti-hypertensive drugs |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Chand Negi |
| Designation |
Professor and Head of Cardiology |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Room no-637C, 6th floor, Department of Cardiology
IGMC
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418103709 |
| Fax |
|
| Email |
negiprakash59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navdha Sharma |
| Designation |
PG Resident |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Room no- 25, first floor PG main girls hostel
IGMC
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9818848787 |
| Fax |
|
| Email |
sharmanavdha7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Chand Negi |
| Designation |
Professor and Head of Cardiology |
| Affiliation |
Indira Gandhi Medical College and Hospital |
| Address |
Room no-637C, 6th floor, Department of Cardiology
IGMC
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418103709 |
| Fax |
|
| Email |
negiprakash59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla, H.P. |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
IGMC, Shimla, 171001 |
| Type of Sponsor |
Government medical college |
|
|
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 Prakash Chand Negi |
Indira Gandhi Medical College |
ROOM 511 E (OPD) and C 637 (Office of HOD Cardiology)
Department of Cardiology IGMC Shimla
171001
Shimla
HIMACHAL PRADESH |
9418103709
9418103709
negiprakash59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIRA GANDHI MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination (FDC) ofTelmisartan(Angiotensin receptor blocker)and
Amlodipine(Calcium channel blocker) |
Dose of FDC single tablet containing temisaratn 40 mg & Amlodipine 5 mg,tablet from, once daily in morning after breakfast. |
| Comparator Agent |
Telmisartan(Angiotensin receptor blocker)
Amlodipine(Calcium channel blocker) |
Dose of free drug combination of:
1.Temisaratn 40 mg, tablet form, once daily in the morning after breakfast.
2.Amlodipine 5 mg, tablet form, once daily in the evening after light meal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly detected hypertensive patients with BP of ≥160/100 mm Hg
2.Established hypertensive; off drug for one week with BP >160/100 to <180/110 mm Hg.
3.Patients age between 18 to 80 years.
4.Willingness to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients age <18 years and >80 years
2. Pregnancy & Lactating females
3. Renal or Hepatic disease
4. Congestive heart disease
5. Established CAD with and without MI
6. Known sensitivity to studied drugs
7. History of CVA & PVD
8. Patient unwilling to participate in the study
8. Elevation in BP >180/110 during withdrawal of antihypertensive drugs
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in Mean Systolic blood pressure and Diastolic blood pressure between Fixed dose combination group and Free drug combination group |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change between groups in proportion of patient achieving target blood pressure
2.Percentage reduction in Systolic and diastolic blood pressure from baseline blood pressure |
2 months |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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 4 |
|
Date of First Enrollment (India)
|
06/07/2015 |
| 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="1"
Months="8"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is the leading risk factor for cardiovascular event (CVE).The substantial proportion of the hypertensive patients are unaware of being hypertensive and among hypertensive patients large proportion are not taking antihypertensive medications, and less than one-third of patients taking hypertensive treatment reach the desired goal of <140/90 mm Hg. The reasons for poor compliance for antihypertensive medications viz unaffordability, non- availability, number of medications prescribed, lack of awareness about importance of keeping BP under control.Thus, there could be role of formulating a fixed drug combination polypill that may lower the cost and number of medications to be taken by the patient and thus improve the compliance.However, there could be a concern regarding drug stability, potency, efficacy, interactions of the drugs combined in the formulations.There are number of pharmaceutical firms manufacturing fixed drug combination with questionable drug potency, efficacy and stability of the formulation.There are studies comparing the antihypertensive efficacy of fixed drug combination with only one of the component of polypill. But there is no study done which compare the antihypertensive efficacy of fixed drug dose combination with both the component of polypill given at similar doses.Thus, the present study aims to assess the antihypertensive efficacy of fixed drug combination Telmisartan 40 mg and Amlodipine 5 mg with free drugs Telmisartan 40 mg and Amlodipine 5 mg used in hypertensive patients.
RECRUITEMENT STATUS - Till date, we recruited 99 patients , out of which 88 completed their 2 months of intervention. Remaining 35 patients will be recruited with in 2-3 months. |