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

Phase 4Active Not RecruitingNCT06041529

Yuhan Corporation198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

198

Conditions

Essential Hypertension

Interventions

Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mgDRUG

PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mgDRUG

PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (15)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

The Catholic University of Korea Bucheon St.Mary's Hospital

Seoul, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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

Time frame: Week 8

Secondary Outcomes

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

Time frame: Week 26 if applicable

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

Time frame: Week 8 and Week 26 if applicable

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

Time frame: Week 8 and Week 26 if applicable

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

Time frame: Week 8 and Week 26 if applicable

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

Data from ClinicalTrials.gov

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