NCT06041529

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg	PO, Once daily(QD), 8 weeks and 26 weeks if applicable
DRUG	Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg	PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Timeline

• Start date: 2023-10-18
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2023-09-18
• Last updated: 2026-02-13

Locations

15 sites across 1 country: South Korea