Clinical trial NCT06041529: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
Official title: An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Mean Systolic Blood Pressure (MSBP) in nighttime
timeFrame: Week 8
Secondary outcomes:
measure: Mean Systolic Blood Pressure (MSBP) in nighttime
timeFrame: Week 26 if applicable
measure: Mean Diastolic Blood Pressure (MDBP) in nighttime
timeFrame: Week 8 and Week 26 if applicable
measure: Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime
timeFrame: Week 8 and Week 26 if applicable
measure: 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)
timeFrame: Week 8 and Week 26 if applicable
measure: Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)
timeFrame: Week 8
measure: Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Week 4, Week 8 and Week 26 if applicable
measure: Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Week 4, Week 8 and Week 26 if applicable
measure: Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).
timeFrame: Week 4, Week 8 and Week 26 if applicable
measure: T/P ratio
timeFrame: Week 8 and Week 26 if applicable
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St.Mary's Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon ST. Mary's Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Veterans Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: he Catholic University of Korea, Incheon ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang university medical center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul national University Budang hospital
Study officials:
affiliation: The Catholic University of Korea Bucheon St.Mary's Hospital
name: Sanghyun Ihm
role: PRINCIPAL_INVESTIGATOR
References: