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

NCT04820907 | Completed Phase 3

• 1 other identifier: HM-CHORUS-301
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Losartan; Chlorthalidone

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean sitting systolic blood pressure(mmHg)

  Week 8

Secondary Outcomes (5)

• 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

Study Arms (2)

HCP1904-1

EXPERIMENTAL

Drug: HCP1904-1

RLD2001-1

ACTIVE COMPARATOR

Drug: RLD2001-1

Interventions

HCP1904-1 DRUG

Take it once daily for 8 weeks orally.

HCP1904-1

RLD2001-1 DRUG

Take it once daily for 8 weeks orally.

RLD2001-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients who understands the process of clinical study and voluntarily signs a peer letter
• 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
• Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: October 27, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

KR (1)