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

NCT07116863 | Completed Phase 3

• 1 other identifier: KDF1901-3H
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blind, multicenter phase 3 clinical trial evaluated the efficacy and safety of KDF1901, a single-pill triple combination of valsartan, amlodipine, and chlorthalidone, in patients with essential hypertension inadequately controlled with dual therapy. A total of 286 patients who remained uncontrolled after a 4-week run-in period with valsartan/amlodipine were randomized to receive either KDF1901 (valsartan/amlodipine/chlorthalidone 160/10/25 mg) or a dual combination of valsartan/amlodipine (160/10 mg) for 8 weeks. The primary endpoint was the change in mean sitting systolic blood pressure (MSSBP) from baseline at week 8. Secondary outcomes included changes in diastolic BP (MSDBP), blood pressure normalization rate, and response rate. KDF1901 demonstrated significantly greater reductions in both MSSBP and MSDBP, with higher normalization and response rates compared to dual therapy. The treatment was well tolerated, and the incidence of adverse events was comparable between groups.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8

  Mean change in sitting systolic blood pressure (MSSBP) after 8 weeks of treatment, measured at trough using a validated automated device.

  Baseline to Week 8

Secondary Outcomes (4)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8

  Baseline to Week 2 and Week 4

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) from baseline to Week 2, Week 4, and Week 8

  Baseline to Week 2, Week 4, and Week 8

• Proportion of subjects achieving target blood pressure at Weeks 2, 4, and 8

  Week 2, Week 4, and Week 8

• Response rate at Weeks 2, 4, and 8

  Week 2, Week 4, and Week

Study Arms (2)

KDF1901 group

EXPERIMENTAL

Run-in Period (4 weeks): KDF1901-R0, a fixed-dose combination tablet containing valsartan 80 mg and amlodipine 5 mg, administered once daily Treatment Period 1 (2 weeks): KDF1901-L, containing valsartan 80 mg, amlodipine 5 mg, and chlorthalidone 12.5 mg, administered once daily Treatment Period 2 (6 weeks): KDF1901, containing valsartan 160 mg, amlodipine 10 mg, and chlorthalidone 25 mg, administered once daily

Drug: KDF1901-R0; Drug: KDF1901-L; Drug: KDF1901

Dual Therapy group

ACTIVE COMPARATOR

Run-in Period (4 weeks): KDF1901-R0, a fixed-dose combination tablet containing valsartan 80 mg and amlodipine 5 mg, administered once daily Treatment Period 1 (2 weeks): KDF1901-R0, same as above, administered once daily Treatment Period 2 (6 weeks): KDF1901-R1, containing valsartan 160 mg and amlodipine 10 mg, administered once daily

Drug: KDF1901-R0; Drug: KDF1901-R1

Interventions

KDF1901-R0 DRUG

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).

Dual Therapy group; KDF1901 group

KDF1901-L DRUG

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.

KDF1901 group

KDF1901 DRUG

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.

KDF1901 group

KDF1901-R1 DRUG

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

Dual Therapy group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged ≥19 years at the time of screening.
• Participants who meet one of the following blood pressure criteria at screening:
• If not currently receiving antihypertensive medication for at least 4 weeks (treatment-naïve):
• Mean Sitting Systolic Blood Pressure (MSSBP) ≥160 mmHg and \<200 mmHg
• If currently receiving antihypertensive medication:
• MSSBP ≥140 mmHg and \<200 mmHg
• For participants with cardiovascular disease, diabetes mellitus, or microalbuminuria (e.g., persistent proteinuria or hematuria), the range is:
• MSSBP ≥130 mmHg and \<200 mmHg
• Willing and able to provide written informed consent prior to participation in the study.
• At baseline (Visit 3), participants must have MSSBP ≥140 mmHg and \<200 mmHg.
• For participants with cardiovascular disease, diabetes mellitus, or microalbuminuria: MSSBP ≥130 mmHg and \<200 mmHg
• At least 70% compliance with run-in period medication, as assessed by tablet count.

You may not qualify if:

• Mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening (Visit 1) or baseline (Visit 3)
• Difference in blood pressure between arms: MSSBP ≥20 mmHg and MSDBP ≥10 mmHg at screening
• History or presence of secondary hypertension or suspected secondary hypertension, including:
• Aortic coarctation, pheochromocytoma, Cushing's syndrome, hyperaldosteronism, polycystic kidney disease
• Severe pulmonary, cardiac, or vascular conditions, such as:
• Pulmonary hypertension, severe heart failure (NYHA class III or IV), hypertrophic cardiomyopathy, aortic aneurysm, thrombocytopathy
• History of serious cardiovascular events or interventions within 24 weeks prior to screening:
• Myocardial infarction, unstable angina, coronary revascularization (PCI/CABG)
• History of cerebrovascular disorders within 24 weeks prior to screening:
• Stroke, TIA, cerebral hemorrhage
• History of ocular conditions within 24 weeks prior to screening:
• Retinal hemorrhage, optic neuropathy, severe visual impairment
• History of malignancy within 5 years prior to screening, except:
• Successfully treated and in remission for ≥2 years, or
• Basal cell carcinoma or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Kyungdong Pharmaceutical Co., Ltd.: lead

Study Sites (2)

CHA Gangnam Medical Center, CHA University

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: June 21, 2022
• Primary Completion: June 20, 2024
• Study Completion: September 13, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)