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Not yet recruitingNCT07660796Updated Jun 30, 2026

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

A Phase 3 interventional study of HCP1803-3 and HCP1803-4 in Hypertension, sponsored by Hanmi Pharmaceutical Company Limited. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Read the detailed description

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension

02

Conditions studied

  • Hypertension

Browse trials for

03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 256 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 190 studies on the registry; 11 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

    • mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
    • 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
  2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2

Exclusion criteria

Exclusion Criteria:

  1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
  3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
  4. Secondary hypertensive patient or suspected to be
  5. hematological finding
  6. Severe heart disease or severe neurovascular disease
  7. Moderate or malignant retinopathy
  8. Uncontrolled diabetes mellitus or type I diabetes mellitus
  9. Active gout or hyperuricemia
  10. Severe renal diseases
  11. Severe or active hepatopathy
  12. Hypokalemia or Hyperkalemia
  13. Hyponatremia or Hypernatremia
  14. Hypercalcemia
  15. History of tumor
  16. History of disease
  17. History of alcohol or drug abuse
  18. Positive to pregnancy test, nursing mother, intention on pregnancy
  19. Considered by investigator as not appropriate to participate in the clinical study with other reason
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    HCP1803-4

    Take HCP1803-3 once daily for 2 weeks orally, and then take HCP1803-4 once daily for 8 weeks orally.

    Drug: HCP1803-3 · Drug: HCP1803-4

  • Active comparator
    RLD2001-2

    Take RLD2001-1 once daily for 2 weeks orally, and then take RLD2001-2 once daily for 8 weeks orally.

    Drug: RLD2001-1 · Drug: RLD2001-2

Interventions

  • Test drug

  • DrugHCP1803-4

    Test drug

  • DrugRLD2001-1

    Control drug

  • DrugRLD2001-2

    Control drug

06

What researchers measure

Primary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: Baseline, 10 weeks

Secondary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: Baseline, 2 weeks, 6 weeks

  2. Change from baseline in sitting diastolic blood pressure

    Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks

  3. Proportion of subjects achieving blood pressure control (sitSBP)

    Time frame: 2 weeks, 6 weeks, 10 weeks

  4. Proportion of subjects achieving blood pressure control (sitSBP, sitDBP)

    Time frame: 2 weeks, 6 weeks, 10 weeks

  5. Blood pressure response rate (sitSBP)

    Time frame: 2 weeks, 6 weeks, 10 weeks

  6. Blood pressure response rate (sitSBP, sitDBP)

    Time frame: 2 weeks, 6 weeks, 10 weeks

  7. Treatment response rate

    Time frame: 2 weeks, 6 weeks, 10 weeks

  8. Change from baseline in pulse pressure

    Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07660796
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Jul 6, 2026 (estimated)
Primary completion
Oct 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Jee Won Shon
Contact
jeewon.shon@hanmi.co.kr
+82-2-410-9037
Moo-Yong Rhee, M.D., Ph.D.
principal investigator · Donggguk University Ilsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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