Back to resultsA Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
Primary Purpose
Hypertension
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP2102-1
HPP2104-1
HCP2102-2
HPP2104-2
RLD2106-1
HPP2103-1
RLD2106-2
HPP2103-2
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients aged ≥ 19 years
- Patients who understands the process of clinical study and voluntarily signs a peer letter
Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions
- Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
- Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
- Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
Exclusion Criteria:
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Orthostatic hypotension with symptoms within 3 months prior to visit 1
- Secondary hypertension 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(Ca ≥ 10.5mg/dL)
- 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 other reason
Sites / Locations
- Kyung Hee University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Active Comparator
Arm Description
HCP2102
RLD2106
Outcomes
Primary Outcome Measures
Change from baseline in mean sitting systolic blood pressure(mmHg)
Secondary Outcome Measures
Change from baseline in mean sitting systolic blood pressure(mmHg)
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Change from baseline in mean pulse blood pressure(mmHg)
Target blood pressure reaching rate(%)
Blood pressure responder rate(%)
Full Information
NCT ID
NCT05450601
First Posted
July 5, 2022
Last Updated
July 31, 2022
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT05450601
Brief Title
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
Official Title
A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
HCP2102
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
RLD2106
Intervention Type
Drug
Intervention Name(s)
HCP2102-1
Intervention Description
Take once daily for 2 weeks orally
Intervention Type
Drug
Intervention Name(s)
HPP2104-1
Intervention Description
Placebo drug. Take once daily for 2 weeks orally
Intervention Type
Drug
Intervention Name(s)
HCP2102-2
Intervention Description
Take once daily for 6 weeks orally
Intervention Type
Drug
Intervention Name(s)
HPP2104-2
Intervention Description
Placebo drug. Take once daily for 6 weeks orally
Intervention Type
Drug
Intervention Name(s)
RLD2106-1
Intervention Description
Take once daily for 2 weeks orally
Intervention Type
Drug
Intervention Name(s)
HPP2103-1
Intervention Description
Placebo drug. Take once daily for 2 weeks orally
Intervention Type
Drug
Intervention Name(s)
RLD2106-2
Intervention Description
Take once daily for 6 weeks orally
Intervention Type
Drug
Intervention Name(s)
HPP2103-2
Intervention Description
Placebo drug. Take once daily for 6 weeks orally
Primary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
week 2
Title
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame
week 2, 8
Title
Change from baseline in mean pulse blood pressure(mmHg)
Time Frame
week 2, 8
Title
Target blood pressure reaching rate(%)
Time Frame
week 2, 8
Title
Blood pressure responder rate(%)
Time Frame
week 2, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged ≥ 19 years
Patients who understands the process of clinical study and voluntarily signs a peer letter
Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions
Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
Exclusion Criteria:
Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
Orthostatic hypotension with symptoms within 3 months prior to visit 1
Secondary hypertension 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(Ca ≥ 10.5mg/dL)
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 other reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-A Jung
Phone
82-2-410-9038
Email
jajung@hanmi.co.kr
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Kim, Ph.D
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
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