Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
Launched by YUHAN CORPORATION · Sep 11, 2023
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different combinations of medications to help elderly patients with essential hypertension, which is high blood pressure that isn't well controlled. The researchers want to compare the effectiveness and safety of a fixed-dose combination of Telmisartan, Amlodipine, and Chlorthalidone versus Telmisartan, Amlodipine, and Hydrochlorothiazide. This study is specifically for patients aged 65 and older whose blood pressure remains high despite taking other blood pressure medications.
To be eligible for this trial, participants must be at least 65 years old and have high blood pressure that isn't adequately controlled. This means their blood pressure needs to be in a certain range, depending on whether they are currently taking other medications. Participants will receive the investigational medications and will be monitored for their effectiveness and any side effects. It's important to note that individuals with certain health issues, allergies to medication components, or those who are pregnant or breastfeeding cannot participate. This study aims to find better treatment options for older adults struggling with high blood pressure.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
- • 2. Aged ≥ 65 with essential hypertension
- • 3. 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 Criteria:
- • 1. Patient who has history of drug allergic reactions
- • 2. Known hypersensitivity to components of the investigational product
- • 3. Patient who is unable to stop taking prohibited drugs
- • 4. 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
- • 5. Pregnant or lactating women
- • 6. Patient who is unable to maintain proper night sleep
- • 7. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
- • 8. Administration of other investigational products within 3 months prior to screening.
- • 9. An impossible one who participates in clinical trial by investigator's decision
About Yuhan Corporation
Yuhan Corporation is a leading South Korean pharmaceutical company dedicated to the research, development, manufacturing, and marketing of innovative healthcare solutions. Established in 1926, Yuhan has a robust portfolio that includes prescription medications, over-the-counter products, and biologics, with a strong emphasis on oncology, infectious diseases, and central nervous system disorders. The company is committed to advancing medical science through strategic partnerships, cutting-edge research, and clinical trials aimed at bringing novel therapies to market. Yuhan's dedication to quality and excellence positions it as a prominent player in the global pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, Gyeonggi Do, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gangwon Do, , Korea, Republic Of
Patients applied
Trial Officials
Sanghyun Ihm
Principal Investigator
The Catholic University of Korea Bucheon St.Mary's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported