NCT07116863 - A Multicenter, Randomized, Double-Blind Phase 3 Trial of KDF1901 in Patients With Essential Hypertension | Biotech Hunter

Enrollment

286

Participants

Timeline

Start Date

June 21, 2022

Primary Completion Date

June 20, 2024

Study Completion Date

September 13, 2024

Conditions

Essential Hypertension

Interventions

DRUG

KDF1901-R0

Fixed-dose combination tablet containing valsartan 80 mg and amlodipine 5 mg. Orally administered once daily for 4 weeks during the run-in period, and for 2 weeks during Treatment Period 1(Dual Therapy group).

DRUG

KDF1901-L

"Fixed-dose combination tablet containing valsartan 80 mg, amlodipine 5 mg, and chlorthalidone 12.5 mg.~Orally administered once daily for 2 weeks during Treatment Period 1."

DRUG

KDF1901

"Fixed-dose combination tablet containing valsartan 160 mg, amlodipine 10 mg, and chlorthalidone 25 mg.~Orally administered once daily for 6 weeks during Treatment Period 2."

DRUG

KDF1901-R1

Fixed-dose combination tablet containing valsartan 160 mg and amlodipine 10 mg. Orally administered once daily for 6 weeks during Treatment Period 2.

Trial Locations (2)

Unknown

CHA Gangnam Medical Center, CHA University, Seoul

Seoul National University Hospital, Seoul