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

Yuhan

Status and phase: Not yet enrolling; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg; Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06041529

YMC050

Details and patient eligibility

About

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

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

Enrollment: 250 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent

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

4. Medication compliance of investigational product (Run-in) > 70 %

5. Patient who has measured nighttime blood pressure more than 7 times from the night before the randomized date to the morning of the day of the randomized date (22:00~5:59)

6. Patient with uncontrolled essential hypertension at Visit 2

   • 140 mmHg ≤ MSSBP < 200 mmHg

Exclusion criteria

1. Patient who has secondary hypertension or suspected of secondary hypertension

2. Patient who has orthostatic hypotension with symptoms

3. Patient who has severe hypotension and severe heart disease (NYHA class III~IV)

4. Patient who has been diagnosed with or treated with the following diseases within the last 6 months judged by the investigator to be clinically significant

   • Patient who has ischemic heart disease, peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery
   • Patient who has clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged clinically significant by the investigator
   • Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic valve hemodynamically significant or mitral valve stenosis/reflux
   • Patient who has severe cerebrovascular disease
   • Known moderate or malignant retinopathy

5. Patient who has sleep disorders or apnea during sleep

6. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products

7. Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients

8. Patient with anuria

9. History of malignant tumor

10. Patient with any chronic inflammation disease needed to chronic inflammation therapy

11. Patient with mental defects that may interfere with participation in clinical trials

12. Patient who has history of drug allergic reactions

13. Patient who has angioedema related to ACE inhibitors, ARBs or diuretics

14. Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton.

15. Known hypersensitivity to components of the investigational product

16. Patient who is unable to stop taking prohibited drugs

17. 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

18. Hepatic or renal dysfunction as defined by the following laboratory parameters (eGFR < 30 mL/min/1.73m2, Serum creatinine ≥ 3 mg/dL, AST/ALT > UNL X 3)

19. Hypokalemia (Serum K < 3.0 mmol/L) or hyperkalemia (Serum K > 5.5 mmol/L), hyponatremia (Serum Na < 132.0 mmol/L) or uncontrolled diabetes (HbA1c > 9.0%)

20. Pregnant or lactating women

21. Patient who is unable to maintain proper night sleep

22. History of drug or alcohol dependency within 1 year prior to screening

23. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical

24. Administration of other investigational products within 3 months prior to screening.

25. An impossible one who participates in clinical trial by investigator's decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

Experimental group

Description:

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period

Treatment:

Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Active Comparator group

Description:

Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period

Treatment:

Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg