Essential Hypertension
Conditions
Keywords
Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
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.
Interventions
DRUGTelmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
DRUGTelmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSanghyun Ihm
The Catholic University of Korea Bucheon St.Mary's Hospital
Outcome results
None listed