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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: HCP1803-3; Drug: HPP2003-3; Drug: HPP2004; Drug: RLD2002

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jin-A Jung, Ph.D.; Phone Number: 82-2-410-9038; Email: jajung@hanmi.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
      • Donggguk University Ilsan Hospital
      • Contact: Moo-Yong Rhee, M.D., Ph.D.; Phone Number: 82-31-961-5775

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1.
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
11. Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; HCP1803-3	Drug: HCP1803-3; Take it once daily for 8 weeks orally.; Drug: HPP2004; Placebo drug. Take it once daily for 8 weeks orally.
Active Comparator: Active Comparator; RLD2002	Drug: HPP2003-3; Placebo drug. Take it once daily for 8 weeks orally.; Drug: RLD2002; Take it once daily for 8 weeks orally.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from baseline in pulse pressure	baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Moo-Yong Rhee, M.D., Ph.D., Donggguk University Ilsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: HM-APOLLO-301

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