| CTRI Number |
CTRI/2023/03/051014 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment. |
|
Scientific Title of Study
|
A Prospective, Open label, Randomized, Multicenter, Post marketing study comparing
Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in
subjects with Hypertension and Renal Impairment. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2022/012/IV /Version No. 1.0/Dated 12-Oct-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
sumit.bhushan@glenmarkpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
sumit.bhushan@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director- Clinical Trial Operations |
| Affiliation |
IR Innovate Research Pvt Ltd |
| Address |
Building No C- 120, 3rd Floor Sector - 2, Noida- 201301
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
|
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri East, Mumbai -
400099
|
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri East, Mumbai -
400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chinmoy Barik |
College of Medicine & J.N.M. Hospital |
Department of Medicine,
1st Floor, Room No.-2,College of Medicine & J.N.M. Hospital, Kalyani, Nadia, West Bengal-741235
Nadia
WEST BENGAL |
9830290854
chinmoybk@gmail.com |
| Dr Chandrashekhar S Gillurkar |
Gillurkar Multispeciality Hospital |
Clinical Research Room, ground floor ,
20, Reshimbag, Umred road, Sakkardara, Nagpur-9
Nagpur
MAHARASHTRA |
9890005678
cgillurkar@yahoo.com |
| Dr Sandeep Kumar Gupta |
MV Hospital & Research Center |
Research Department Room No. 7 to 10, Ground Floor,314/30, Mirza Mandi, Chowk, Lucknow-226003 Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Harsh Mittal |
Panchsheel Hospital Pvt. Ltd. |
Clinical Research Room no.-01
Block - C3, 64/A, Block C, Yamuna Vihar, Shahdara, Delhi, 110053
North East
DELHI |
9560506410
harshmittal86@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
Room No. 310,3rd floor
6/1, Promenade Rd, Near Coles Park, Frazer Town, Bengaluru, Karnataka 560005
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
| Dr Mukulesh Gupta |
Udyan Health Care Pvt. Ltd. |
Basement Room No-11
730, Udayn-1 Eldeco, Near Bangla Bazar, Lucknow(U.P.) 226012
Lucknow
UTTAR PRADESH |
9336046146
drmukulesh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Gillurkar Hospital Ethics Committee |
Approved |
| I. E. C., College of Medicine and JNM Hospita |
Approved |
| Institutional Ethics Committee for MV Hospital and Research centre |
Approved |
| Institutional Ethics Committee Panchsheel Hospital |
Approved |
| Santosh Hospital-Institutional Ethics Committee |
Approved |
| The Institutional Human EC, Udyaan Health Care |
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 |
FDC of Telmisartan 40/80 mg
and Amlodipine 5mg |
1 tablet to be taken once daily,
orally with plain water after
meal, daily for 365 days. |
| Comparator Agent |
FDC of Telmisartan 40/80 mg
and Cilnidipine 10 mg
|
1 tablet to be taken once daily,
orally with plain water after
meal, daily for 365 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged between 18 to 75 years
2. Subjects with the ability to understand and provide written informed consent forms which must have been obtained prior to screening.
3. Subjects with hypertension (systolic/diastolic BP more than or equal to 130/80 and less than 180/110 mmHg
4. Subjects with hypertension and renal impairment eGFR more than or equal to 60 ml/min/1.73m2 and
urinary albumin in the range of 30–600 mg/g creatinine
5. Subjects with hypertension requiring antihypertensive treatment with two drug
therapy
6. Subjects on a stable dose of antihypertensive treatment with Telmisartan for more than or equal to 3 months before the enrolment;
7. Subjects not on CCB treatment for their hypertension management for more than or equal to 3 months before the enrolment
8. Subjects willing to comply with the protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. Presence of any clinically relevant disease/disorder (e.g., severe hepatic
impairment, chronic renal failure, thromboembolic disorders, coronary artery or
cerebrovascular diseases, uncontrolled diabetes (HbA1c more than or equal to 7%), uncontrolled thyroid
disorder etc.)
2. Causes of renal disease other than hypertension or T2DM
3. Urinary tract infections
4. Acute Kidney Injury (AKI)
5. Subjects of T1DM
6. Subjects of T2DM diagnosed more than 1 year prior to screening
7. Severe hypertension (more than or equal to 180/110 mmHg)
8. Serum creatinine more than or equal to 2.0 mg/dL in men or more than or equal to1.5 mg/dL in women
9. Subjects, in the opinion of investigators, requiring initiation of treatment with initial
monotherapy
10. Surgical or medical condition that, in the judgment of the Investigator, could
interfere with the absorption, distribution, metabolism, or excretion of the drugs to be
used.
11. Presence or history of secondary or malignant hypertension.
12. Any known cardiac disease/disorder in which any of the study medications is
contra-indicated.
13. Current or recent substance abuse, including alcohol.
14. Refusal or inability to comply with the requirements of the protocol for any
the reason, including scheduled clinic visits and laboratory tests.
15. Participation in any experimental drug study within 60 days before screening.
16. Breast feeding or pregnant females or Females with child-bearing potential who
do not follow adequate contraceptive measures.
17. Concomitant or prior (within 60 days of screening) use of any of the following
medications: calcium channel blocker, clonidine, aliskerin.
18. Subjects having intolerance, hypersensitivity or any other contraindication to
any of the Investigational products.
19. History of HIV, Hepatitis B and Hepatitis C.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline in urinary
albumin-creatinine ratio (UACR) |
Time Frame: Day 0, Day 180 & Day 365 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of Telmisartan plus Amlodipine Vs. Telmisartan
plus Cilnidipine in subjects suffering from hypertension and renal impairment by the-
• Change from baseline in estimated glomerular filtration rate (eGFR) at Week 52
• Change from baseline in office blood pressure at Week 52
• Change from baseline in serum creatinine levels at Week 52
• Change from baseline in serum uric acid levels at Week 52
To evaluate and compare the safety of Telmisartan plus Amlodipine Vs. Telmisartan
plus Cilnidipine in subjects suffering from hypertension and renal impairment by the-
• Incidence of adverse effects of Telmisartan plus Amlodipine Vs. Telmisartan
plus Cilnidipine at follow up visits of treatment
|
Time Frame: Day 0, Day 180 & Day 365 |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
Final Enrollment numbers achieved (Total)= "188"
Final Enrollment numbers achieved (India)="228" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/03/2023 |
| Date of Study Completion (India) |
25/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication done yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Prospective, Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment. Hypertension (HTN) is a public health menace contributing to up to 45% of cardiovascular disease (CVD) deaths and 51% of stroke deaths. In India, up to 33% of the urban and 25% of the rural population are afflicted with the disease. Attainment of blood pressure (BP) goals in the population at large is a major challenge and area of focus of health systems worldwide. Over the years, BP targets have been continuously redefined as the armamentarium of drugs has expanded. The recently published the American College of Cardiology/American Heart Association (ACC/AHA) 2017 HTN guidelines advocate a paradigm shift in the way we manage abnormal BP This is a Prospective, Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment. 188 subjects (94 in each group) will be randomized in this study across 6 centers across India. The treatment duration of each subject will be 52 weeks. Change in UACR from baseline till Week 52 will be primarily evaluated. Change in eGFR, office blood pressure, serum creatinine levels, and serum uric acid levels will be evaluated as a secondary endpoint. |