- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04830449
Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients
September 20, 2023 updated by: Hanmi Pharmaceutical Company Limited
A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients.
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HCP1904-2
|
Take it once daily for 8 weeks orally.
|
Active Comparator: RLD2001-2
|
Take it once daily for 8 weeks orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: Week 4
|
Week 4
|
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame: Week 4,8
|
Week 4,8
|
Change from baseline in mean pulse blood pressure(mmHg)
Time Frame: Week 4,8
|
Week 4,8
|
Responder rate
Time Frame: Week 4, 8
|
Week 4, 8
|
target blood pressure reach rate
Time Frame: Week 4, 8
|
Week 4, 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2020
Primary Completion (Actual)
August 24, 2021
Study Completion (Actual)
August 24, 2021
Study Registration Dates
First Submitted
March 31, 2021
First Submitted That Met QC Criteria
March 31, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-CHORUS-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
Clinical Trials on HCP1904-2
-
Hanmi Pharmaceutical Company LimitedNot yet recruitingHealthyKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompleted
-
Hanmi Pharmaceutical Company LimitedCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics CorporationCompletedRetinal DegenerationUnited Kingdom
-
Yuhan CorporationCompletedRheumatic ArthritisKorea, Republic of
-
Medifast, Inc.Completed
-
University of South CarolinaTerminatedSedentary Lifestyle | Knee Osteoarthritis | Knee Injuries | Knee Pain ChronicUnited States
-
University of PennsylvaniaNational Cancer Institute (NCI); PfizerCompleted