Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension

Launched by YUHAN CORPORATION · Sep 11, 2023

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