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

Y

Yuhan

Status and phase

Not yet enrolling
Phase 4

Conditions

Essential Hypertension

Treatments

Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06041529
YMC050

Details and patient eligibility

About

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

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
Experimental group
Description:
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period
Treatment:
Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Active Comparator group
Description:
Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period
Treatment:
Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Trial contacts and locations

0

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Central trial contact

Yujun Kim; Minjun Kim

Data sourced from clinicaltrials.gov

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