Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04820907

Enrollment

123

Registered

2021-03-29

Start date

2020-10-27

Completion date

2021-09-30

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Losartan, Chlorthalidone

Brief summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-1 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, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients

Interventions

DRUGHCP1904-1

Take it once daily for 8 weeks orally.

DRUGRLD2001-1

Take it once daily for 8 weeks orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 8

Secondary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 4
Change from baseline in mean sitting diastolic blood pressure(mmHg)	Week 4,8
Change from baseline in mean pulse blood pressure(mmHg)	Week 4,8
Responder rate	Week 4, 8
target blood pressure reach rate	Week 4, 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026