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CompletedNCT04959305HM_APOLLOUpdated Jul 14, 2022

A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension

A Phase 2 interventional study of HCP1803-3 and RLD2003 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 2022-07-14.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

A multicenter, randomized, double-blind, parallel, phase 2 study to explore the dose of HCP1803 in patients with essential hypertension

02

Conditions studied

  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 245 is above the median of 90 across 4,995 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 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 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 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. Orthostatic hypotension with symptoms within 3 months prior to 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. Moderate or malignant retinopathy
  8. Clinically significant hematological finding
  9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
  10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
  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 other reason
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    Experimental 1

    HCP1803-3

    Drug: HCP1803-3 · Drug: HPP2005

  • Active comparator
    Active Comparator 1

    RLD2003

    Drug: RLD2003 · Drug: HPP2003-3

  • Active comparator
    Active Comparator 2

    RLD2004

    Drug: RLD2004 · Drug: HPP2003-3

  • Active comparator
    Active Comparator 3

    RLD2005

    Drug: RLD2005 · Drug: HPP2003-3

Interventions

  • DrugHCP1803-3

    Take it once daily for 8 weeks orally.

  • DrugRLD2003

    Take it once daily for 8 weeks orally.

  • DrugRLD2004

    Take it once daily for 8 weeks orally.

  • DrugRLD2005

    Take it once daily for 8 weeks orally.

  • DrugHPP2003-3

    Placebo drug. Take it once daily for 8 weeks orally.

  • DrugHPP2005

    Placebo drug. Take it once daily for 8 weeks orally.

06

What researchers measure

Primary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: baseline, 4 weeks

  2. Change from baseline in sitting distolic blood pressure

    Time frame: baseline, 4 weeks, 8 weeks

  3. Proportion of subjects achieving blood pressure control

    Time frame: 4 weeks, 8 weeks

  4. Proportion of responder

    Time frame: baseline, 4 weeks, 8 weeks

  5. Change from baseline in pulse pressure(sitSBP - sitDBP)

    Time frame: baseline, 4 weeks, 8 weeks

07

Study locations

1 site
  • Donggguk University Ilsan Hospital
    Goyang-si, Gyeonggi-do 10326, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04959305
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Jul 13, 2021
Start date
Apr 22, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Jul 14, 2022

Study contacts

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 completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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