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

Sponsor
Yuhan Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06041529
Collaborator
(none)
250
12
2
21.4
20.8
1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
  • Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 14, 2023
Anticipated Primary Completion Date :
Feb 21, 2025
Anticipated Study Completion Date :
Jun 27, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

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

Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Other Names:
  • Truset 40/5/12.5mg
  • Active Comparator: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

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

    Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
    PO, Once daily(QD), 8 weeks and 26 weeks if applicable
    Other Names:
  • Twynsta 40/5 mg, Dichlozid 25 mg
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    7. 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

    8. 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

    9. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Signed informed consent

    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

    1. Medication compliance of investigational product (Run-in) > 70 %

    2. 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)

    3. Patient with uncontrolled essential hypertension at Visit 2

    • 140 mmHg ≤ MSSBP < 200 mmHg
    Exclusion Criteria:
    1. Patient who has secondary hypertension or suspected of secondary hypertension

    2. Patient who has orthostatic hypotension with symptoms

    3. Patient who has severe hypotension and severe heart disease (NYHA class III~IV)

    4. 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

    1. Patient who has sleep disorders or apnea during sleep

    2. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products

    3. Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients

    4. Patient with anuria

    5. History of malignant tumor

    6. Patient with any chronic inflammation disease needed to chronic inflammation therapy

    7. Patient with mental defects that may interfere with participation in clinical trials

    8. Patient who has history of drug allergic reactions

    9. Patient who has angioedema related to ACE inhibitors, ARBs or diuretics

    10. Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton.

    11. Known hypersensitivity to components of the investigational product

    12. Patient who is unable to stop taking prohibited drugs

    13. 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
    1. 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)

    2. 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%)

    3. Pregnant or lactating women

    4. Patient who is unable to maintain proper night sleep

    5. History of drug or alcohol dependency within 1 year prior to screening

    6. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical

    7. Administration of other investigational products within 3 months prior to screening.

    8. An impossible one who participates in clinical trial by investigator's decision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea Bucheon St.Mary's Hospital Seoul Gyeonggi-do Korea, Republic of 14647
    2 The Catholic University of Korea Daejeon ST. Mary's Hospital Daejeon Korea, Republic of 34943
    3 Chonnam National University Hospital Gwangju Korea, Republic of 61469
    4 The Catholic University of Korea, ST. Vincent's Hospital Gyeonggi-do Korea, Republic of 16247
    5 he Catholic University of Korea, Incheon ST. Mary's Hospital Incheon Korea, Republic of 21431
    6 The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Korea, Republic of 03312
    7 Hanyang university medical center Seoul Korea, Republic of 04763
    8 The Catholic University of Korea Seoul Korea, Republic of 06591
    9 The Catholic University of Korea, Yeouido ST. Mary's Hospital Seoul Korea, Republic of 07345
    10 Korea University Guro Hospital Seoul Korea, Republic of 08308
    11 The Catholic University of Korea, Uijeongbu ST. Mary's Hospital Seoul Korea, Republic of 11765
    12 Seoul national University Budang hospital Seoul Korea, Republic of 13620

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    • Principal Investigator: Sanghyun Ihm, The Catholic University of Korea Bucheon St.Mary's Hospita

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT06041529
    Other Study ID Numbers:
    • YMC050
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuhan Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2023