Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
- Conditions
- Essential Hypertension
- Interventions
- Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mgDrug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
- Registration Number
- NCT06041529
- Lead Sponsor
- Yuhan Corporation
- Brief 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
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
-
Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
-
Aged ≥ 65 with essential hypertension
-
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
-
Patient who has history of drug allergic reactions
-
Known hypersensitivity to components of the investigational product
-
Patient who is unable to stop taking prohibited drugs
-
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
-
Pregnant or lactating women
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Patient who is unable to maintain proper night sleep
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Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
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Administration of other investigational products within 3 months prior to screening.
-
An impossible one who participates in clinical trial by investigator's decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period
- Primary Outcome Measures
Name Time Method Mean Systolic Blood Pressure (MSBP) in nighttime Week 8 To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8
- Secondary Outcome Measures
Name Time Method Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime Week 8 and Week 26 if applicable 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
Mean Systolic Blood Pressure (MSBP) in nighttime Week 26 if applicable To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable
Mean Diastolic Blood Pressure (MDBP) in nighttime Week 8 and Week 26 if applicable 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
Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP) Week 8 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
Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP) Week 4, Week 8 and Week 26 if applicable - 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
Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP). Week 4, Week 8 and Week 26 if applicable 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
Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP) Week 4, Week 8 and Week 26 if applicable 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
T/P ratio Week 8 and Week 26 if applicable 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
24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) Week 8 and Week 26 if applicable 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
Trial Locations
- Locations (15)
Pusan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Korea, Republic of
Gwangju Veterans Hospital
🇰🇷Gwangju, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷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 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
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang university medical center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul national University Budang hospital
🇰🇷Seoul, Korea, Republic of