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

An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients With Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

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 Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

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, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential hypertension uncontrolled by Telmisartan and Amlodipine Combinations.

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