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
Study 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
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
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
Primary outcome measure(s)
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
Trial sites (15)
Facility
City
Region
Status
Wonju Severance Christian Hospital
Wŏnju
Gangwon-do
The Catholic University of Korea Bucheon St.Mary's Hospital
Seoul
Gyeonggi-do
Pusan National University Yangsan Hospital
Busan
South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon
South Korea
Chonnam National University Hospital
Gwangju
South Korea
Gwangju Veterans Hospital
Gwangju
South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do
South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon
South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
South Korea
Hanyang university medical center
Seoul
South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
South Korea
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul
South Korea
Korea University Guro Hospital
Seoul
South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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