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A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension (HM_APOLLO)

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HCP1803-3

RLD2002

HPP2003-3

HPP2004

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:

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
- 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ 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 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Exclusion Criteria:

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
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason

Sites / Locations

Donggguk University Ilsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Active Comparator

Arm Description

HCP1803-3

RLD2002

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

Blood pressure response rate

Treatment response rate

Change from baseline in pulse pressure

Full Information

NCT ID

NCT05362110

First Posted

May 1, 2022

Last Updated

September 24, 2023

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT05362110

Brief Title

A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

Acronym

HM_APOLLO

Official Title

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

June 5, 2023 (Actual)

Study Completion Date

June 5, 2023 (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

5. Study Description

Brief Summary

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety 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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

361 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

HCP1803-3

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

RLD2002

Intervention Type

Drug

Intervention Name(s)

HCP1803-3

Intervention Description

Take it once daily for 8 weeks orally.

Intervention Type

Drug

Intervention Name(s)

RLD2002

Intervention Description

Take it once daily for 8 weeks orally.

Intervention Type

Drug

Intervention Name(s)

HPP2003-3

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

HPP2004

Intervention Description

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

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

Time Frame

4 weeks, 8 weeks

Title

Blood pressure response rate

Time Frame

4 weeks, 8 weeks

Title

Treatment response rate

Time Frame

4 weeks, 8 weeks

Title

Change from baseline in pulse pressure

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: 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 1 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ 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 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2 Exclusion Criteria: 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 History of alcohol or drug abuse Positive to pregnancy test, nursing mother, intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with other reason

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

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A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

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