Status:
RECRUITING
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
Lead Sponsor:
Yuhan Corporation
Conditions:
Essential Hypertension
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Ess...
Detailed Description
This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination) versus Telmisartan,...
Eligibility Criteria
Inclusion
- Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
- Aged ≥ 65 with essential hypertension
- Patient with uncontrolled essential hypertension at screening
- If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg
- If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg
Exclusion
- Patient who has history of drug allergic reactions
- Known hypersensitivity to components of the investigational product
- Patient who is unable to stop taking prohibited drugs
- Test results showing the following values at screening
- The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements
- Pregnant or lactating women
- Patient who is unable to maintain proper night sleep
- Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
- Administration of other investigational products within 3 months prior to screening.
- An impossible one who participates in clinical trial by investigator's decision
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06041529
Start Date
October 18 2023
End Date
October 28 2025
Last Update
November 18 2024
Active Locations (15)
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1
The Catholic University of Korea Bucheon St.Mary's Hospital
Seoul, Gyeonggi-do, South Korea, 14647
2
Pusan National University Yangsan Hospital
Busan, South Korea, 50612
3
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, South Korea, 34943
4
Wonju Severance Christian Hospital
Gangwon-do, South Korea, 26426