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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg | Experimental | Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period |
|
| Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg | Active Comparator | Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg | Drug | PO, Once daily(QD), 8 weeks and 26 weeks if applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Diastolic Blood Pressure (MDBP) in nighttime |
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Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant or lactating women
Patient who is unable to maintain proper night sleep
Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
Administration of other investigational products within 3 months prior to screening.
An impossible one who participates in clinical trial by investigator's decision
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| Name | Affiliation | Role |
|---|---|---|
| Sanghyun Ihm | The Catholic University of Korea Bucheon St.Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea | ||
| The Catholic University of Korea Bucheon St.Mary's Hospital |
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|
| Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg | Drug | PO, Once daily(QD), 8 weeks and 26 weeks 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 |
| 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 | 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 | 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 | Week 8 |
| 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 |
| 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 |
| 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 |
| 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 |
| Seoul |
| Gyeonggi-do |
| 14647 |
| South Korea |
| Pusan National University Yangsan Hospital | Busan | 50612 | South Korea |
| The Catholic University of Korea Daejeon ST. Mary's Hospital | Daejeon | 34943 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Gwangju Veterans Hospital | Gwangju | 62284 | South Korea |
| The Catholic University of Korea, ST. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| The Catholic University of Korea, Incheon ST. Mary's Hospital | Incheon | 21431 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | 03312 | South Korea |
| Hanyang university medical center | Seoul | 04763 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul | 07345 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital | Seoul | 11765 | South Korea |
| Seoul national University Budang hospital | Seoul | 13620 | South Korea |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D002752 | Chlorthalidone |
| D006852 | Hydrochlorothiazide |
| C548840 | telmisartan amlodipine combination |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
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