NCT03897868

Brief Summary

A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship 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
248

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Mar 2019

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

March 21, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

March 29, 2019

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 (7)

Experimental 1

EXPERIMENTAL

HCP1803 High

Drug: HCP1803Drug: Placebo

Experimental 2

EXPERIMENTAL

HCP1803 Middle

Drug: HCP1803Drug: Placebo

Experimental 3

EXPERIMENTAL

HCP1803 Low

Drug: HCP1803Drug: Placebo

Active Comparator 1

ACTIVE COMPARATOR

HGP0904 High

Drug: Amlodipine

Active Comparator 2

ACTIVE COMPARATOR

HGP0904 Low

Drug: AmlodipineDrug: Placebo

Active Comparator 3

ACTIVE COMPARATOR

HGP0608

Drug: LosartanDrug: Placebo

Placebo Comparator

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HCP1803DRUG

HCP1803

Experimental 1Experimental 2Experimental 3
AmlodipineDRUG

Amlodipine

Active Comparator 1Active Comparator 2
LosartanDRUG

Losartan

Active Comparator 3
PlaceboDRUG

Placebo

Active Comparator 2Active Comparator 3Experimental 1Experimental 2Experimental 3Placebo Comparator

Eligibility Criteria

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

You may qualify if:

  • Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 1, Visit 2

You may not qualify if:

  • Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  • Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
  • Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
  • Patient with secondary hypertension

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)

  • Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.

    PMID: 33408462DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

AmlodipineLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesTetrazoles

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

March 29, 2019

First Posted

April 1, 2019

Study Start

March 21, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)