| CTRI Number |
CTRI/2018/08/015555 [Registered on: 31/08/2018] Trial Registered Prospectively |
| Last Modified On: |
16/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the effect of two different combinations of BP medication in patients with uncontrolled BP |
|
Scientific Title of Study
|
A clinical assessment to evaluate the effect of two different combinations of anti-hypertensive drugs (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg among Subjects with uncontrolled hypertension in India – A prospective, randomized, investigator initiated study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARI/TELMA/01-18, Version No. 02, dated 25 July 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D C Venkata S Ram |
| Designation |
Director Apollo Institute for Blood Pressure Management and Apollo Blood Pressure Clinics |
| Affiliation |
Apollo Hospitals |
| Address |
Director Apollo Institute for Blood Pressure Management and Apollo Blood Pressure Clinics Apollo Hospitals Jubilee Hills Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
7799806040 |
| Fax |
|
| Email |
drram_v@apollohospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D C Venkata S Ram |
| Designation |
Director Apollo Institute for Blood Pressure Management and Apollo Blood Pressure Clinics |
| Affiliation |
Apollo Hospitals |
| Address |
Director Apollo Institute for Blood Pressure Management and Apollo Blood Pressure Clinics Apollo Hospitals Jubilee Hills Hyderabad Telangana
ANDHRA PRADESH
500096
India |
| Phone |
7799806040 |
| Fax |
|
| Email |
drram_v@apollohospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
G Praveen Kumar |
| Designation |
Sr Manager |
| Affiliation |
Apollo Research And Innovations |
| Address |
Apollo Research And Innovations Auditorium Building 1st Floor Apollo Medical College Apollo Hospitals Jubilee Hills Hyderabad
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
9948161123 |
| Fax |
|
| Email |
praveen999biotech@gmail.com |
|
|
Source of Monetary or Material Support
|
| Current Medical Concepts Pvt Ltd,
401, Lumbini Lakeview Apts, 6-3-1239/27,
Raj Bhavan Road, Somajiguda, Hyderabad – 500082, Telangana State, India |
|
|
Primary Sponsor
|
| Name |
Current Medical Concepts Pvt Ltd |
| Address |
401 Lumbini Lakeview Apts 6-3-1239/27 Raj Bhavan Road Somajiguda Hyderabad Telangana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Partha Saradhi |
Apollo DRDO Hospitals |
Department of Internal Medicine, 1st floor, Room number-24, Kanchan Bagh
Hyderabad
ANDHRA PRADESH |
8790277017
drparthanephro@gmail.com |
| Dr Hari Kishan Boorugu |
Apollo Hospitals |
Department of Internal Medicine, 1st Floor, Room number-15,Hyderguda, Near old MLA quarters
Hyderabad
ANDHRA PRADESH |
9642767757
drharikishan@gmail.com |
| Dr Shalini Muppalla |
Apollo Institute of Medical Science and Research |
Department of General medicine, Ground floor, General Hospital, Apollo Medical College, Apollo Health City Jubilee Hills
Hyderabad
ANDHRA PRADESH |
9490896948
shalinimuppalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Institutional Ethics Committee - Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combinations of antihypertensive drugs (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10) mg |
This study will have simple random sampling procedure (Alternate assignment) to randomize the Subjects to Group A and B. Subjects eligible for recruitment will be alternately assigned to combination therapy Group A or Group B. This sequence will be followed at each site independently. Subjects in both the groups will have to take the study drugs orally once in a day for eight weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Adults greater than or equal to 18 years and
less than or equal to 70 years old both male
and female.
b) Subjects with uncontrolled BP who are on
monotherapy.
c) Systolic Blood Pressure (SBP) >130 mmHg and
Diastolic Blood Pressure (DBP) > 80
mmHg based on three consecutive blood
pressure readings
d) Any stage of Hypertension.
e) Willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
a) Women of child bearing potential
b) History of Myocardial infarction, Acute
stroke, Acute kidney injury in the last 3
months
c) Subjects with history of congestive heart
failure.
d) Subjects with advanced CKD with Serum
Creatinine value > 2.5 mg/dL.
e) History of allergy to calcium channel
blockers and angiotensin receptor blockers
f) Inability to give informed consent
g) Subject with hypertensive crisis (Seated BP
greater than or equal to 180/120 mmHg) on
the day of screening.
h) Subjects unwilling/unable to adhere to the
study protocol.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of two different treatments on BP levels in Subjects with Hypertension |
Screening and Week 8 (end of study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of combination therapy from baseline to end of study |
Between Baseline to end of study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2018 |
| Date of Study Completion (India) |
20/04/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an investigator initiated study to evaluate the effect of two different combinations of antihypertensive treatments that are already approved and marketed in India for so long. However, the current study is planned to evaluate the role of combination therapy on BP levels as per the new hypertension guidelines. The drugs that will be used in this study are as follows: (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg) This study is planned to be conducted across three centers with a sample size 100.
|