| CTRI Number |
CTRI/2018/02/011727 [Registered on: 06/02/2018] Trial Registered Prospectively |
| Last Modified On: |
03/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
observational study in patients with blood pressure |
|
Scientific Title of Study
|
An Open label Multicenter Non Interventional Observational Study to Evaluate Efficacy of Telmisartan 80 mg Amlodipine 10 mg or 5mg and Chlorthalidone 12.5 mg compared to continuation of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual therapy in Hypertensive patients not responding to four weeks of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual Combination therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukul Misra |
| Designation |
Professor |
| Affiliation |
RMLIMS |
| Address |
Dept. of cardiology, Gomti Nagar, lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
|
| Fax |
|
| Email |
mukul_sk_misra1@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Garg |
| Designation |
Medical Director |
| Affiliation |
Dr Reddys laboratories ltd. |
| Address |
8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
amitgard@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ritesh Khandelwal |
| Designation |
Head Clinical Research |
| Affiliation |
QREC Clinical Research LLP |
| Address |
211 sc no 1 first floor
Alwar
RAJASTHAN
301001
India |
| Phone |
|
| Fax |
|
| Email |
bd@qreccr.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills,
Hyderabad - 500034. Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
8-2-337, Road No. 3, Banjara Hills,
Hyderabad - 500034. Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Noushadali Shaik |
AC subbareddy govt. medical college |
Dept. of Internal Medicine
Nellore
ANDHRA PRADESH |
9494828694
projectspcr@gmail.com |
| Dr Mukul Misra |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Dept of cardiology Lucknow, Uttar Pradesh – 226010
Lucknow
UTTAR PRADESH |
9450959088
mukul_sk_misra1@yahoo.com |
| Dr Abhijeet deshmukh |
Ishwar Institute of healthcare |
dept. of general medicine, Aurangabad
Aurangabad
MAHARASHTRA |
9834820181
ishwarresearch@gmail.com |
| Dr M Pavan Kumar |
Mahatma gandhi memorial hospital |
Dept. of general medicne, warangal, telangana
Warangal
ANDHRA PRADESH |
9849453664
titanpavank@gmail.com |
| Dr A Gopal Rao |
RIMS |
Dept of general medicine, srikakulam
Srikakulam
ANDHRA PRADESH |
9440122790
drgopalrao@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AC Subbareddy govt. medical college |
Approved |
| Ishwar institute of healthcare |
Approved |
| mahatma gandhi memoral hospital |
Approved |
| RIMS |
Approved |
| RMLIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, Male and female treatment naïve patients, aged 18–80 years, with diagnosis of Stage II essential hypertension (DBP 100–114 mm Hg and SBP 160–199mm Hg), |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female treatment naïve patients, aged 18–80 years, with diagnosis of Stage II essential hypertension (DBP 100–114 mm Hg and SBP 160–199mm Hg) at entry, who are considered appropriate for initial dual therapy with Telmisartan 80 mg+ Amlodipine 5mg/ 10 mg
2. Patients who have inadequate blood pressure control (DBP >90 mm Hg) but have shown atleast 2 mm DBP reduction after 4 weeks of dual therapy will be selected for treatment allocation of triple therapy or dual therapy
NOTE –patients with initial DBP of 100-109mmHg generally initiated on telmisartan 80 mg + Amlodipine 5mg and those with DBP 110-114 mm Hg initiated on telmisartan 80 Mg + amlodipine 10mg. |
|
| ExclusionCriteria |
| Details |
1. Patients already taking antihypertensive drugs at screening (since the study is intended to enroll treatment naïve patients)
2.Patients not ready to refrain from taking treatment with other drugs that could interfere with the evaluation of efficacy and tolerability.
3.Patients with secondary hypertension (eg. due to renal artery stenosis etc.)
4.Patients with uncontrolled diabetes mellitus, significant cardiovascular or cerebrovascular disease [congestive heart failure (New York Heart Association class III/IV); unstable angina in the previous 3 months; stroke within the previous 6 months; myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angiography in the previous 3 months; cardiac arrhythmia; cardiomyopathy; aortic or mitral valve stenosis]
5.Patients with renal or hepatic disease (based on known history or lab abnormalities) or serum electrolyte abnormalities |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in mean Seated trough DBP (Week 12) |
Change from baseline in mean Seated trough DBP (Week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in
ï‚· Mean Seated trough SBP (Week 12)
ï‚· Mean standing trough SBP (Week 12)
ï‚· Mean standing trough DBP (Week 12)
Responder Rate (Week 12) A normalized blood pressure response defined as SBP140 mm Hg and DBP90 mm Hg, an optimal blood pressure response defined as SBP130mm Hg and DBP 80 mm Hg, and a DBP response defined as DBP90 mm Hg. |
week 12 |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "600"
Final Enrollment numbers achieved (India)="600" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/02/2018 |
| Date of Study Completion (India) |
10/05/2019 |
| 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
|
Publication will be done by sponsor |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background :Hypertension poses a severe health risk to the Indian population. The prevalence of hypertension is on the rise in India and Worldwide. This study is planned as post marketing non-interventional observational study to be conducted in India to assess to assess efficacy and safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg. The efficacy and safety for the treatment regimen of Telmisartan + Amlodipine dual combination therapy has been well established through enough clinical evidence. The combination is widely prescribed by the physicians. However there are cases where the patient does not respond to the treatment regimen and target blood pressure ranges are not reached even though the patient adheres to the treatment regimen prescribed by the physician. This may be due to inadequate treatment regimen. This becomes a problem for the patient as well as the physician, as uncontrolled blood pressure leads to other high risk complications (CVD‟s, chronic kidney disease etc.,). Such kind of non responder patient population prevalence is on the rise in India. Considering the rise in prevalence of hypertension in India and also rise in treatment non responders an alternative treatment regimen might be warranted. Our objective is to assess the efficacy and safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg triple drug combination for effective management of stage II hypertension in patients who are not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg.
Primary objective: To evaluate efficacy of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg
Secondary objective: To evaluate safety of Telmisartan 80 mg + Amlodipine 10 mg/ 5mg + Chlorthalidone 12.5 mg in hypertensive patients not responding to four weeks of dual therapy with Telmisartan 80 mg + Amlodipine 10 mg/ 5mg
Cohort 1*: Telmisartan 80 mg + Amlodipine 5 mg/10 mg + Chlorthalidone 12.5 mg Cohort 2: Telmisartan 80 mg + Amlodipine 5 mg/10 mg *Patients not responding to Telmisartan 80 mg + Amlodipine 5 mg/10 mg dual therapy to receive triple therapy with corresponding dose of Telmisartan and Amlodipine. No provision of increasing dose of patients initiated on Telmisartan 80 mg + Amlodipine 5 mg to Telmisartan 80 mg + Amlodipine 10 mg |