Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

NCT ID: NCT05199129

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-09-14

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HCP1904-3

Group Type: EXPERIMENTAL

HCP1904-3

Intervention Type: DRUG

Take once daily for 8 weeks orally

RLD2001-1

Intervention Type: DRUG

Take once daily for 8 weeks orally

RLD2001-1

Group Type: ACTIVE_COMPARATOR

HCP1904-3

Intervention Type: DRUG

Take once daily for 8 weeks orally

RLD2001-1

Intervention Type: DRUG

Take once daily for 8 weeks orally

Interventions

HCP1904-3

Take once daily for 8 weeks orally

Intervention Type: DRUG

RLD2001-1

Take once daily for 8 weeks orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients over 19 years of age

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

3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

• Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
• Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg

4. Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg

Exclusion Criteria

1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP

2. Orthostatic hypotension with symptoms within 3months of 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. 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

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 othe reason

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-CHORUS-303

Identifier Type: -

Identifier Source: org_study_id