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A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension (HM_APOLLO)

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HCP1803

Amlodipine

Losartan

Placebo

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Donggguk University Ilsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental 1

Experimental 2

Experimental 3

Active Comparator 1

Active Comparator 2

Active Comparator 3

Placebo Comparator

Arm Description

HCP1803 High

HCP1803 Middle

HCP1803 Low

HGP0904 High

HGP0904 Low

HGP0608

Placebo

Outcomes

Primary Outcome Measures

Change from baseline in sitting systolic blood pressure

Secondary Outcome Measures

Change from baseline in sitting systolic blood pressure

Change from baseline in sitting distolic blood pressure

Proportion of subjects achieving blood pressure control

sitSBP/sitDBP < 140/90 mmHg

Proportion of responder

Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg

Change from baseline in pulse pressure(sitSBP - sitDBP)

Full Information

NCT ID

NCT03897868

First Posted

March 29, 2019

Last Updated

July 12, 2022

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT03897868

Brief Title

A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Acronym

HM_APOLLO

Official Title

A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

March 21, 2019 (Actual)

Primary Completion Date

February 26, 2020 (Actual)

Study Completion Date

February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

248 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental 1

Arm Type

Experimental

Arm Description

HCP1803 High

Arm Title

Experimental 2

Arm Type

Experimental

Arm Description

HCP1803 Middle

Arm Title

Experimental 3

Arm Type

Experimental

Arm Description

HCP1803 Low

Arm Title

Active Comparator 1

Arm Type

Active Comparator

Arm Description

HGP0904 High

Arm Title

Active Comparator 2

Arm Type

Active Comparator

Arm Description

HGP0904 Low

Arm Title

Active Comparator 3

Arm Type

Active Comparator

Arm Description

HGP0608

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

HCP1803

Intervention Description

HCP1803

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Intervention Description

Amlodipine

Intervention Type

Drug

Intervention Name(s)

Losartan

Intervention Description

Losartan

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in sitting systolic blood pressure

Time Frame

baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in sitting systolic blood pressure

Time Frame

baseline, 4 weeks

Title

Change from baseline in sitting distolic blood pressure

Time Frame

baseline, 4 weeks, 8 weeks

Title

Proportion of subjects achieving blood pressure control

Description

sitSBP/sitDBP < 140/90 mmHg

Time Frame

4 weeks, 8 weeks

Title

Proportion of responder

Description

Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg

Time Frame

baseline, 4 weeks, 8 weeks

Title

Change from baseline in pulse pressure(sitSBP - sitDBP)

Time Frame

baseline, 4 weeks, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moo-Yong Rhee, M.D., Ph.D.

Organizational Affiliation

Donggguk University Ilsan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Donggguk University Ilsan Hospital

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

10326

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33408462

Citation

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. Erratum In: Drug Des Devel Ther. 2021 Apr 07;15:1477.

Results Reference

derived

Learn more about this trial

A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

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