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

NCT ID: NCT03897868

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2020-02-26

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 1

HCP1803 High

Group Type EXPERIMENTAL

HCP1803

Intervention Type DRUG

HCP1803

Placebo

Intervention Type DRUG

Placebo

Experimental 2

HCP1803 Middle

Group Type EXPERIMENTAL

HCP1803

Intervention Type DRUG

HCP1803

Placebo

Intervention Type DRUG

Placebo

Experimental 3

HCP1803 Low

Group Type EXPERIMENTAL

HCP1803

Intervention Type DRUG

HCP1803

Placebo

Intervention Type DRUG

Placebo

Active Comparator 1

HGP0904 High

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine

Active Comparator 2

HGP0904 Low

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine

Placebo

Intervention Type DRUG

Placebo

Active Comparator 3

HGP0608

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Losartan

Placebo

Intervention Type DRUG

Placebo

Placebo Comparator

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HCP1803

HCP1803

Intervention Type DRUG

Amlodipine

Amlodipine

Intervention Type DRUG

Losartan

Losartan

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Donggguk University Ilsan Hospital

Locations

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Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33408462 (View on PubMed)

Other Identifiers

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HM-APOLLO-201

Identifier Type: -

Identifier Source: org_study_id

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