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

July 12, 2022 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
HCP1803 High
Placebo
HCP1803
Experimental: Experimental 2
HCP1803 Middle
Placebo
HCP1803
Experimental: Experimental 3
HCP1803 Low
Placebo
HCP1803
Active Comparator: Active Comparator 1
HGP0904 High
Amlodipine
Active Comparator: Active Comparator 2
HGP0904 Low
Placebo
Amlodipine
Active Comparator: Active Comparator 3
HGP0608
Placebo
Losartan
Placebo Comparator: Placebo Comparator
Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 8 weeks
baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change from baseline in sitting distolic blood pressure
Time Frame: baseline, 4 weeks, 8 weeks
baseline, 4 weeks, 8 weeks
Change from baseline in pulse pressure(sitSBP - sitDBP)
Time Frame: baseline, 4 weeks, 8 weeks
baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control
Time Frame: 4 weeks, 8 weeks
sitSBP/sitDBP < 140/90 mmHg
4 weeks, 8 weeks
Proportion of responder
Time Frame: baseline, 4 weeks, 8 weeks
Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg
baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Moo-Yong Rhee, M.D., Ph.D., Donggguk University Ilsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2019

Primary Completion (Actual)

February 26, 2020

Study Completion (Actual)

February 26, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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