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

Status and phase

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

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

  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

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

15

There are currently no registered sites for this trial.

Central trial contact

bokyung Lee; Minjun Kim

Timeline

Last updated: Nov 18, 2024

Start date

Oct 18, 2023 • 1 year and 2 months ago

Today

Jan 07, 2025

End date

Jun 24, 2025 • in 5 months

Sponsor of this trial

Lead Sponsor

Data sourced from clinicaltrials.gov