A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension
NCT ID: NCT04959305
Last Updated: 2022-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
245 participants
INTERVENTIONAL
2021-04-22
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension
NCT05362110
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
NCT05450601
A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
NCT03897868
Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients
NCT04830449
A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension
NCT06438172
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental 1
HCP1803-3
HCP1803-3
Take it once daily for 8 weeks orally.
HPP2005
Placebo drug. Take it once daily for 8 weeks orally.
Active Comparator 1
RLD2003
RLD2003
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
Active Comparator 2
RLD2004
RLD2004
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
Active Comparator 3
RLD2005
RLD2005
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HCP1803-3
Take it once daily for 8 weeks orally.
RLD2003
Take it once daily for 8 weeks orally.
RLD2004
Take it once daily for 8 weeks orally.
RLD2005
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
HPP2005
Placebo drug. Take it once daily for 8 weeks orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
* 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 2
Exclusion Criteria
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1.
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moo-Yong Rhee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Donggguk University Ilsan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sung KC, Hong SJ, Rhee MY, Jeong MH, Kim DH, Lim SW, Park K, Lee JB, Kim SY, Cho JM, Cho GY, Heo JH, Kim SH, Lee HY, Kim W, Cho DK, Park S, Shin J, Pyun WB, Kwon K, Rha SW, Jung JA. Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension. J Clin Hypertens (Greenwich). 2023 May;25(5):429-439. doi: 10.1111/jch.14656. Epub 2023 Apr 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HM-APOLLO-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.