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CompletedNCT05199129Updated Sep 22, 2023

Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

A Phase 3 interventional study of HCP1904-3 and RLD2001-1 in Hypertension, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

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

Phase
Phase 3
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Read the detailed description

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

02

Conditions studied

  • Hypertension

Keywords

  • Losartan
  • Chlorthalidone
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 166 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 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

Inclusion criteria

  1. Patients over 19 years of age
  2. Patients who understands the process of clinical study and voluntarily signs a peer letter
  3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

    • Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
    • Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
  4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

Exclusion criteria

Exclusion Criteria:

  1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
  2. Orthostatic hypotension with symptoms within 3months of visit 1
  3. Secondary hypertensive patient or suspected to be
  4. Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
  5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
  6. Severe heart disease or severe neurovascular disease
  7. Severe or malignant retinopathy
  8. Clinically significant hematological finding
  9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
  10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
  11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
  12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
  13. Hypercalcemia
  14. History of malignancy tumor
  15. History of autoimmune disease
  16. History of alcohol or drug abuse
  17. Positive to pregnancy test, nursing mother, intention on pregnancy
  18. Considered by investigator as not appropriate to participate in the clinical study with othe reason
05

Study design

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

Study arms

  • Experimental
    HCP1904-3

    Drug: HCP1904-3 · Drug: RLD2001-1

  • Active comparator
    RLD2001-1

    Drug: HCP1904-3 · Drug: RLD2001-1

Interventions

  • DrugHCP1904-3

    Take once daily for 8 weeks orally

  • DrugRLD2001-1

    Take once daily for 8 weeks orally

06

What researchers measure

Primary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week 4

  2. Change from baseline in mean sitting diastolic blood pressure(mmHg)

    Time frame: Week 4,8

  3. Change from baseline in mean pulse blood pressure(mmHg)

    Time frame: Week 4,8

  4. Target blood pressure reach rate(%)

    Time frame: Week 4,8

  5. Blood pressure responder rate(%)

    Time frame: Week 4,8

07

Study locations

1 site
  • Severance Hospital
    Seoul, 03722, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05199129
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Nov 17, 2021
Primary completion
Sep 14, 2022
Completion
Sep 14, 2022
Last update
Sep 22, 2023

Oversight

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

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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