A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: RLD2106-1; Drug: HCP2102-1; Drug: HPP2103-1; Drug: HPP2104-1; Drug: RLD2106-2; Drug: HCP2102-2; Drug: HPP2104-2; Drug: HPP2103-2

• Registration Number: NCT05450601
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Study Start: 2022-09-01
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

1. Patients aged ≥ 19 years

2. Patients who understands the process of clinical study and voluntarily signs a peer letter

3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

   • Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
   • Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

4. Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

Exclusion Criteria

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
3. Secondary hypertension 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. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
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(Ca ≥ 10.5mg/dL)
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	HPP2104-2	HCP2102
Active Comparator	RLD2106-2	RLD2106
Active Comparator	HPP2103-1	RLD2106
Active Comparator	HPP2103-2	RLD2106
Active Comparator	RLD2106-1	RLD2106
Experimental	HCP2102-1	HCP2102
Experimental	HPP2104-1	HCP2102
Experimental	HCP2102-2	HCP2102

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	week 2
Change from baseline in mean sitting diastolic blood pressure(mmHg)	week 2, 8
Change from baseline in mean pulse blood pressure(mmHg)	week 2, 8
Target blood pressure reaching rate(%)	week 2, 8
Blood pressure responder rate(%)	week 2, 8

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of