Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent
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Aged ≥ 65 with essential hypertension
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Patient with uncontrolled essential hypertension at screening
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If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg
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If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg
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Medication compliance of investigational product (Run-in) > 70 %
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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)
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Patient with uncontrolled essential hypertension at Visit 2
- 140 mmHg ≤ MSSBP < 200 mmHg
Exclusion Criteria:
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Patient who has secondary hypertension or suspected of secondary hypertension
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Patient who has orthostatic hypotension with symptoms
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Patient who has severe hypotension and severe heart disease (NYHA class III~IV)
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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
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Patient who has ischemic heart disease, peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery
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Patient who has clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged clinically significant by the investigator
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Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic valve hemodynamically significant or mitral valve stenosis/reflux
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Patient who has severe cerebrovascular disease
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Known moderate or malignant retinopathy
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Patient who has sleep disorders or apnea during sleep
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Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products
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Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients
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Patient with anuria
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History of malignant tumor
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Patient with any chronic inflammation disease needed to chronic inflammation therapy
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Patient with mental defects that may interfere with participation in clinical trials
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Patient who has history of drug allergic reactions
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Patient who has angioedema related to ACE inhibitors, ARBs or diuretics
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Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton.
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Known hypersensitivity to components of the investigational product
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Patient who is unable to stop taking prohibited drugs
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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
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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)
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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%)
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Pregnant or lactating women
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Patient who is unable to maintain proper night sleep
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History of drug or alcohol dependency within 1 year prior to screening
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Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
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Administration of other investigational products within 3 months prior to screening.
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An impossible one who participates in clinical trial by investigator's decision
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- YMC050