NCT04959305

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 1, 2021

Last Update Submit

July 12, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitting systolic blood pressure

    baseline, 8 weeks

Secondary Outcomes (5)

  • Change from baseline in sitting systolic blood pressure

    baseline, 4 weeks

  • Change from baseline in sitting distolic blood pressure

    baseline, 4 weeks, 8 weeks

  • Proportion of subjects achieving blood pressure control

    4 weeks, 8 weeks

  • Proportion of responder

    baseline, 4 weeks, 8 weeks

  • Change from baseline in pulse pressure(sitSBP - sitDBP)

    baseline, 4 weeks, 8 weeks

Study Arms (4)

Experimental 1

EXPERIMENTAL

HCP1803-3

Drug: HCP1803-3Drug: HPP2005

Active Comparator 1

ACTIVE COMPARATOR

RLD2003

Drug: RLD2003Drug: HPP2003-3

Active Comparator 2

ACTIVE COMPARATOR

RLD2004

Drug: RLD2004Drug: HPP2003-3

Active Comparator 3

ACTIVE COMPARATOR

RLD2005

Drug: RLD2005Drug: HPP2003-3

Interventions

HCP1803-3DRUG

Take it once daily for 8 weeks orally.

Experimental 1
RLD2003DRUG

Take it once daily for 8 weeks orally.

Active Comparator 1
RLD2004DRUG

Take it once daily for 8 weeks orally.

Active Comparator 2
RLD2005DRUG

Take it once daily for 8 weeks orally.

Active Comparator 3
HPP2003-3DRUG

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

Active Comparator 1Active Comparator 2Active Comparator 3
HPP2005DRUG

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

Experimental 1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  • Orthostatic hypotension with symptoms within 3 months prior to visit 1.
  • Secondary hypertensive patient or suspected to be
  • Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
  • Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
  • Severe heart disease or severe neurovascular disease
  • Moderate or malignant retinopathy
  • Clinically significant hematological finding
  • Severe renal diseases (eGFR\<30mL/min/1.73m2)
  • Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
  • Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
  • Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
  • Hypercalcemia
  • History of malignancy tumor
  • History of autoimmune disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Related Publications (1)

  • Sung KC, Hong SJ, Rhee MY, Jeong MH, Kim DH, Lim SW, Park K, Lee JB, Kim SY, Cho JM, Cho GY, Heo JH, Kim SH, Lee HY, Kim W, Cho DK, Park S, Shin J, Pyun WB, Kwon K, Rha SW, Jung JA. Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension. J Clin Hypertens (Greenwich). 2023 May;25(5):429-439. doi: 10.1111/jch.14656. Epub 2023 Apr 24.

    PMID: 37095689DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Moo-Yong Rhee, M.D., Ph.D.

    Donggguk University Ilsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 13, 2021

Study Start

April 22, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)