Clinical Efficacy and Safety Evaluation of HCP1904-2 in E... | NCT04830449

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

NCT04830449

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

122Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

HCP1904-2
RLD2001-2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2020Actual

Primary Completion Date

Aug 24, 2021Actual

Completion Date

Aug 24, 2021Actual

First Submitted Date

Mar 31, 2021

First Submission Date that Met QC Criteria

Mar 31, 2021

First Posted Date

Apr 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2023

Last Update Posted Date

Sep 22, 2023Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Label	Type	Description	Intervention Names
HCP1904-2	Experimental		Drug: HCP1904-2
RLD2001-2	Active Comparator		Drug: RLD2001-2

Name	Type	Description	Arm Group Labels	Other Names
HCP1904-2	Drug	Take it once daily for 8 weeks orally.	HCP1904-2
RLD2001-2

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

Measure	Description	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)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases