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Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent 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 Medication compliance of investigational product (Run-in) > 70 % Patient who has measured nighttime blood pressure more than 7 times from the night before the randomized date to the morning of the day of the randomized date (22:00~5:59) Patient with uncontrolled essential hypertension at Visit 2 140 mmHg ≤ MSSBP < 200 mmHg Exclusion Criteria: Patient who has secondary hypertension or suspected of secondary hypertension Patient who has orthostatic hypotension with symptoms Patient who has severe hypotension and severe heart disease (NYHA class III~IV) Patient who has been diagnosed with or treated with the following diseases within the last 6 months judged by the investigator to be clinically significant Patient who has ischemic heart disease, peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery Patient who has clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged clinically significant by the investigator Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic valve hemodynamically significant or mitral valve stenosis/reflux Patient who has severe cerebrovascular disease Known moderate or malignant retinopathy Patient who has sleep disorders or apnea during sleep Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients Patient with anuria History of malignant tumor Patient with any chronic inflammation disease needed to chronic inflammation therapy Patient with mental defects that may interfere with participation in clinical trials Patient who has history of drug allergic reactions Patient who has angioedema related to ACE inhibitors, ARBs or diuretics Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton. 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 Hepatic or renal dysfunction as defined by the following laboratory parameters (eGFR < 30 mL/min/1.73m2, Serum creatinine ≥ 3 mg/dL, AST/ALT > UNL X 3) Hypokalemia (Serum K < 3.0 mmol/L) or hyperkalemia (Serum K > 5.5 mmol/L), hyponatremia (Serum Na < 132.0 mmol/L) or uncontrolled diabetes (HbA1c > 9.0%) Pregnant or lactating women Patient who is unable to maintain proper night sleep History of drug or alcohol dependency within 1 year prior to screening 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

Sites / Locations

  • The Catholic University of Korea Bucheon St.Mary's Hospital
  • The Catholic University of Korea Daejeon ST. Mary's Hospital
  • Chonnam National University Hospital
  • The Catholic University of Korea, ST. Vincent's Hospital
  • he Catholic University of Korea, Incheon ST. Mary's Hospital
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Hanyang university medical center
  • The Catholic University of Korea
  • The Catholic University of Korea, Yeouido ST. Mary's Hospital
  • Korea University Guro Hospital
  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
  • Seoul national University Budang hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Arm Description

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period

Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mean Diastolic Blood Pressure (MDBP) in nighttime
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
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)
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)
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)
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)
- 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).
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
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

Full Information

First Posted
September 4, 2023
Last Updated
September 11, 2023
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT06041529
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 14, 2023 (Anticipated)
Primary Completion Date
February 21, 2025 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
Arm Type
Experimental
Arm Description
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period
Arm Title
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Arm Type
Active Comparator
Arm Description
Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
Other Intervention Name(s)
Truset 40/5/12.5mg
Intervention Description
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Other Intervention Name(s)
Twynsta 40/5 mg, Dichlozid 25 mg
Intervention Description
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Primary Outcome Measure Information:
Title
Mean Systolic Blood Pressure (MSBP) in nighttime
Description
To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Mean Systolic Blood Pressure (MSBP) in nighttime
Description
To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable
Time Frame
Week 26 if applicable
Title
Mean Diastolic Blood Pressure (MDBP) in nighttime
Description
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
Time Frame
Week 8 and Week 26 if applicable
Title
Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime
Description
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
Time Frame
Week 8 and Week 26 if applicable
Title
24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)
Description
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
Time Frame
Week 8 and Week 26 if applicable
Title
Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)
Description
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
Time Frame
Week 8
Title
Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)
Description
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
Time Frame
Week 4, Week 8 and Week 26 if applicable
Title
Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)
Description
- 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
Time Frame
Week 4, Week 8 and Week 26 if applicable
Title
Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).
Description
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
Time Frame
Week 4, Week 8 and Week 26 if applicable
Title
T/P ratio
Description
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
Time Frame
Week 8 and Week 26 if applicable

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent 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 Medication compliance of investigational product (Run-in) > 70 % Patient who has measured nighttime blood pressure more than 7 times from the night before the randomized date to the morning of the day of the randomized date (22:00~5:59) Patient with uncontrolled essential hypertension at Visit 2 140 mmHg ≤ MSSBP < 200 mmHg Exclusion Criteria: Patient who has secondary hypertension or suspected of secondary hypertension Patient who has orthostatic hypotension with symptoms Patient who has severe hypotension and severe heart disease (NYHA class III~IV) Patient who has been diagnosed with or treated with the following diseases within the last 6 months judged by the investigator to be clinically significant Patient who has ischemic heart disease, peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery Patient who has clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged clinically significant by the investigator Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic valve hemodynamically significant or mitral valve stenosis/reflux Patient who has severe cerebrovascular disease Known moderate or malignant retinopathy Patient who has sleep disorders or apnea during sleep Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients Patient with anuria History of malignant tumor Patient with any chronic inflammation disease needed to chronic inflammation therapy Patient with mental defects that may interfere with participation in clinical trials Patient who has history of drug allergic reactions Patient who has angioedema related to ACE inhibitors, ARBs or diuretics Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton. 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 Hepatic or renal dysfunction as defined by the following laboratory parameters (eGFR < 30 mL/min/1.73m2, Serum creatinine ≥ 3 mg/dL, AST/ALT > UNL X 3) Hypokalemia (Serum K < 3.0 mmol/L) or hyperkalemia (Serum K > 5.5 mmol/L), hyponatremia (Serum Na < 132.0 mmol/L) or uncontrolled diabetes (HbA1c > 9.0%) Pregnant or lactating women Patient who is unable to maintain proper night sleep History of drug or alcohol dependency within 1 year prior to screening 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujun Kim
Phone
+82-2-828-0394
Email
yjkim@yuhan.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Minjun Kim
Phone
+82-2-828-0508
Email
minjun.kim@yuhan.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanghyun Ihm
Organizational Affiliation
The Catholic University of Korea Bucheon St.Mary's Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea Bucheon St.Mary's Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanghyun lhm
Facility Name
The Catholic University of Korea Daejeon ST. Mary's Hospital
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungsun Cho
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juhan Kim
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihee Kim
Facility Name
he Catholic University of Korea, Incheon ST. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mijung Kim
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukmin Seo
Facility Name
Hanyang university medical center
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinho Shin
Facility Name
The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunho Choo
Facility Name
The Catholic University of Korea, Yeouido ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunjoo Cho
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinoh Na
Facility Name
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
11765
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyosuk Ahn
Facility Name
Seoul national University Budang hospital
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwangil Kim

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension

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