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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041529
• Other study ID #: YMC050
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 14, 2023
• Est. completion date: June 27, 2025

Study information

• Verified date: September 2023
• Source: Yuhan Corporation
• Contact: Yujun Kim
• Phone: +82-2-828-0394
• Email: yjkim[@]yuhan.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 27, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
• Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	he Catholic University of Korea, Incheon ST. Mary's Hospital	Incheon
Korea, Republic of	Hanyang university medical center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul national University Budang hospital	Seoul
Korea, Republic of	The Catholic University of Korea	Seoul
Korea, Republic of	The Catholic University of Korea Bucheon St.Mary's Hospital	Seoul	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Systolic Blood Pressure (MSBP) in nighttime	To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8	Week 8
Secondary	Mean Systolic Blood Pressure (MSBP) in nighttime	To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable	Week 26 if applicable
Secondary	Mean Diastolic Blood Pressure (MDBP) in nighttime	To evaluate change from baseline in nighttime Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable	Week 8 and Week 26 if applicable
Secondary	Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime	To evaluate change from baseline in daytime Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable	Week 8 and Week 26 if applicable
Secondary	24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)	To evaluate change from baseline in 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable	Week 8 and Week 26 if applicable
Secondary	Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)	To evaluate the percentage of patients who reached the treatment goal for nighttime Mean Systolic Blood Pressure (MSBP) (<110/65mmHg) measured by Ambulatory Blood Pressure Monitoring at Week 8	Week 8
Secondary	Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)	To evaluate change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP) measured by the Institution at Week 4, Week 8 and Week 26 if applicable	Week 4, Week 8 and Week 26 if applicable
Secondary	Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)	- To evaluate the percentage of patients who reached the treatment goal for Mean Sitting Blood Pressure (MSBP) < 140/90 mmHg measured by the Institution at Week 4, Week 8 and Week 26 if applicable	Week 4, Week 8 and Week 26 if applicable
Secondary	Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).	To evaluate the percentage of subjects with a Mean Sitting Systolic Blood Pressure (MSSBP) decrease of =20mmHg and a Mean Sitting Diastolic Blood Pressure (MSDBP) decrease of =10mmHg at Week 4, Week 8 and Week 26 if applicable	Week 4, Week 8 and Week 26 if applicable
Secondary	T/P ratio	To evaluate the T/P ratio for systolic/diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable	Week 8 and Week 26 if applicable