Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

NCT ID: NCT04830449

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-29
• Study Completion Date: 2021-08-24

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

Conditions

Hypertension

Study Design

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

Study Groups

HCP1904-2

Group Type: EXPERIMENTAL

HCP1904-2

Intervention Type: DRUG

Take it once daily for 8 weeks orally.

RLD2001-2

Group Type: ACTIVE_COMPARATOR

RLD2001-2

Intervention Type: DRUG

Take it once daily for 8 weeks orally.

Interventions

HCP1904-2

Take it once daily for 8 weeks orally.

Intervention Type: DRUG

RLD2001-2

Take it once daily for 8 weeks orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients over 18 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

• Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
• Orthostatic hypotension with symptoms within 3months of 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
• Severe or malignant retinopathy
• Clinically significant hematological finding
• Severe renal diseases (eGFR<30mL/min/1.73m2)
• Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
• 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 othe reason

• Minimum Eligible Age: 18 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-302

Identifier Type: -

Identifier Source: org_study_id