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

NCT05362110 | Completed Phase 3

• 1 other identifier: HM-APOLLO-301
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sitting systolic blood pressure

  baseline, 8 weeks

Secondary Outcomes (6)

• 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

• Blood pressure response rate

  4 weeks, 8 weeks

• Treatment response rate

  4 weeks, 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

HCP1803-3

Drug: HCP1803-3; Drug: HPP2004

Active Comparator

ACTIVE COMPARATOR

RLD2002

Drug: RLD2002; Drug: HPP2003-3

Interventions

HCP1803-3 DRUG

Take it once daily for 8 weeks orally.

Experimental

RLD2002 DRUG

Take it once daily for 8 weeks orally.

Active Comparator

HPP2003-3 DRUG

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

Active Comparator

HPP2004 DRUG

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

Experimental

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Moo-Yong Rhee, M.D., Ph.D.

  Donggguk University Ilsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 5, 2022
• Study Start: May 16, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)