Essential HypertensionPhase 3NCT07116863
A Multicenter, Randomized, Double-Blind Phase 3 Trial of KDF1901 in Patients With Essential Hypertension
A Phase 3 study testing KDF1901-R0, KDF1901-L and KDF1901 in people with Essential Hypertension, run by Kyungdong Pharmaceutical Co., Ltd. at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- KDF1901-R0, KDF1901-L and KDF1901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Jun 2022to 13 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 42Show fewer
- 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
- Hereditary blood disorders or history of angioedema related to ACE inhibitors or ARBs
- History of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) within 48 weeks prior to screening
- Clinically significant conditions affecting drug absorption, distribution, metabolism, or excretion
- Symptoms of orthostatic hypotension or risk of falls or syncope
- Severe anemia, leukopenia, or thrombocytopenia at screening
- Heart failure NYHA class III or IV
- Known serious arrhythmias, including ventricular tachycardia or fibrillation
- Known autoimmune disease or connective tissue disorder
- Clinically significant renal, hepatic, or cardiovascular disease
- eGFR <30 mL/min/1.73 m² or serum creatinine ≥2.0 mg/dL
- ALT or AST >3× upper limit of normal (ULN)
- Serum K+ <3.5 or >5.5 mmol/L, Na+ <135 mmol/L, Ca2+ >10.5 or <2.63 mmol/L
- Requiring long-term immunosuppressive therapy or systemic corticosteroids
- Clinically significant chronic inflammatory conditions
- History of major surgery or active GI disorders
- Type 2 diabetes mellitus with HbA1c ≥9.0%
- Known edematous disorders (e.g., untreated nephrotic syndrome)
- Requirement for prohibited medications (emergency drugs) during study period (Visit 1-6)
- Use of lithium therapy
- Use of terfenadine or astemizole
- Hypersensitivity to study drugs, dihydropyridine-class CCBs, thiazide diuretics, or sulfonamides
- History or suspicion of drug or alcohol abuse
- Pregnancy or lactation
- Women of childbearing potential or male participants not agreeing to use reliable contraception during study
- Participation in other clinical trials or use of investigational products within 4 weeks prior to screening
- Judged by the investigator to be otherwise unsuitable for study participation
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
CHA Gangnam Medical Center, CHA University
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Randomized, Double-Blind, Multi-Center, Phase III Trial to Evaluate the Efficacy and Safety of KDF1901 in Patients With Essential Hypertension Inappropriately Controlled on KDF1901-R0 Treatment
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.
Read the detailed description
Achieving optimal blood pressure control remains a clinical challenge, especially in patients who do not respond adequately to dual antihypertensive therapy. This study assessed the clinical benefit of adding chlorthalidone to a fixed-dose combination of valsartan and amlodipine to form KDF1901, a triple combination therapy.
The study included 286 patients with essential hypertension who did not reach target blood pressure after a 4-week run-in period with valsartan/amlodipine (80/5 mg). They were randomized 1:1 to receive either KDF1901 (160/10/25 mg) or valsartan/amlodipine (160/10 mg) for 8 weeks.
At week 8, the KDF1901 group showed significantly greater reductions in MSSBP (-21.2 ± 9.3 mmHg vs. -15.4 ± 8.7 mmHg, p<0.001) and MSDBP (-12.2 ± 6.5 mmHg vs. -8.6 ± 6.2 mmHg, p<0.001) than the dual therapy group. Blood pressure normalization and response rates were also significantly higher with KDF1901.
Subgroup analyses revealed consistent efficacy in elderly and diabetic patients. The incidence of TEAEs was similar between groups, and most adverse events were mild and not drug-related. These results suggest the potential clinical utility of chlorthalidone-based triple therapy in high-risk hypertensive patients.
- Conditions
- Essential Hypertension
- Being tested
- KDF1901-R0, KDF1901-L, KDF1901, KDF1901-R1
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDF1901-R0Drug
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).
KDF1901-LDrug
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.
KDF1901Drug
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-R1Drug
Fixed-dose combination tablet containing valsartan 160 mg and amlodipine 10 mg. Orally administered once daily for 6 weeks during Treatment Period 2.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: KDF1901-R0; Drug: KDF1901-R1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (4)
Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8
Mean change in MSSBP after 2 and 4 weeks of treatment, compared to baseline.
Measured: 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
Mean change in MSDBP measured at trough using an automated device.
Measured: Baseline to Week 2, Week 4, and Week 8
Proportion of subjects achieving target blood pressure at Weeks 2, 4, and 8
Proportion of subjects achieving MSSBP <140 mmHg and MSDBP <90 mmHg. For subjects with diabetes mellitus, target BP is MSSBP <130 mmHg and MSDBP <80 mmHg.
Measured: Week 2, Week 4, and Week 8
Response rate at Weeks 2, 4, and 8
Proportion of subjects who achieved a reduction of ≥20 mmHg in MSSBP or ≥10 mmHg in MSDBP from baseline.
Measured: Week 2, Week 4, and Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start21 Jun 2022
- Primary completion20 Jun 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungdong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116863
- Sponsor's protocol ID
- KDF1901-3H
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HY, Suh SY, Youn HJ, Chung WB, Han KH, Ahn Y, Cha DH, Kim SH, Park JS, Kim CK, Kim JS, Shin JH, Yoon MH, Lee JB, Kim JH, Jeon DS, Yu CW, Kim MH, Lim KH, Sohn IS, Jeong JO, Park CG, Choi YJ, Lee CH, Jeong J, Yoon SB, Kwon SU, Yeo SH, Kim CJ. Efficacy and Safety Profile of a Triple Single-Pill Combination of Valsartan/Amlodipine/Chlorthalidone in Patients with Uncontrolled Hypertension. Clin Ther. 2026 Jun 8:S0149-2918(26)00156-6. doi: 10.1016/j.clinthera.2026.05.010. Online ahead of print.
PubMed 42259717
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multi-Center, Phase III Trial to Evaluate the Efficacy and Safety of KDF1901 in Patients With Essential Hypertension Inappropriately Controlled on KDF1901-R0 Treatment
- ClinicalTrials.gov ID
- NCT07116863
- Acronym / sponsor ID
- KDF1901-3H
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Kyungdong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Achieving optimal blood pressure control remains a clinical challenge, especially in patients who do not respond adequately to dual antihypertensive therapy. This study assessed the clinical benefit of adding chlorthalidone to a fixed-dose combination of valsartan and amlodipine to form KDF1901, a triple combination therapy.
The study included 286 patients with essential hypertension who did not reach target blood pressure after a 4-week run-in period with valsartan/amlodipine (80/5 mg). They were randomized 1:1 to receive either KDF1901 (160/10/25 mg) or valsartan/amlodipine (160/10 mg) for 8 weeks.
At week 8, the KDF1901 group showed significantly greater reductions in MSSBP (-21.2 ± 9.3 mmHg vs. -15.4 ± 8.7 mmHg, p<0.001) and MSDBP (-12.2 ± 6.5 mmHg vs. -8.6 ± 6.2 mmHg, p<0.001) than the dual therapy group. Blood pressure normalization and response rates were also significantly higher with KDF1901.
Subgroup analyses revealed consistent efficacy in elderly and diabetic patients. The incidence of TEAEs was similar between groups, and most adverse events were mild and not drug-related. These results suggest the potential clinical utility of chlorthalidone-based triple therapy in high-risk hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KDF1901 group | Experimental | Drug: KDF1901-R0, Drug: KDF1901-L, Drug: KDF1901Run-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 |
| Dual Therapy group | Active comparator | Drug: KDF1901-R0, Drug: KDF1901-R1Run-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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female participants aged ≥19 years at the time of screening.
- Participants who meet one of the following blood pressure criteria at screening:
- 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.
Key exclusion criteria (42 listed)
- 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:
- Severe pulmonary, cardiac, or vascular conditions, such as:
- History of serious cardiovascular events or interventions within 24 weeks prior to screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDF1901-R0Fixed-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 | Dual Therapy group, KDF1901 group |
| KDF1901-LFixed-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 group |
| KDF1901Fixed-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 group |
| KDF1901-R1Fixed-dose combination tablet containing valsartan 160 mg and amlodipine 10 mg. Orally administered once daily for 6 weeks during Treatment Period 2. | Drug | Dual Therapy group |
Primary outcome
Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8
Time frame: 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.
4 secondary outcomes
Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8
Time frame: 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
Time frame: Baseline to Week 2, Week 4, and Week 8
Proportion of subjects achieving target blood pressure at Weeks 2, 4, and 8
Time frame: Week 2, Week 4, and Week 8
Response rate at Weeks 2, 4, and 8
Time frame: Week 2, Week 4, and Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 42259717Lee HY, Suh SY, Youn HJ, Chung WB, Han KH, Ahn Y, Cha DH, Kim SH, Park JS, Kim CK, Kim JS, Shin JH, Yoon MH, Lee JB, Kim JH, Jeon DS, Yu CW, Kim MH, Lim KH, Sohn IS, Jeong JO, Park CG, Choi YJ, Lee CH, Jeong J, Yoon SB, Kwon SU, Yeo SH, Kim CJ. Efficacy and Safety Profile of a Triple Single-Pill Combination of Valsartan/Amlodipine/Chlorthalidone in Patients with Uncontrolled Hypertension. Clin Ther. 2026 Jun 8:S0149-2918(26)00156-6. doi: 10.1016/j.clinthera.2026.05.010. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KDF1901-R0, KDF1901-L and KDF1901 in people with Essential Hypertension, run by Kyungdong Pharmaceutical Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Sitting Systolic Blood Pressure (MSSBP) from baseline to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07116863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.