A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension
NCT ID: NCT06438172
Last Updated: 2025-02-19
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
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COMPLETED
PHASE3
249 participants
INTERVENTIONAL
2024-03-25
2024-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental
HCP1803-3
HCP1803-3
Take it once daily for 8 weeks orally.
HPP2002-1
Placebo drug. Take it once daily for 8 weeks orally.
Active Comparator
RLD2001-1
RLD2001-1
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
Interventions
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HCP1803-3
Take it once daily for 8 weeks orally.
RLD2001-1
Take it once daily for 8 weeks orally.
HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
HPP2002-1
Placebo drug. Take it once daily for 8 weeks orally.
Eligibility Criteria
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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 60 mmHg ≤ 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 60 mmHg ≤ 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
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Moo-Yong Rhee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Donggguk University Ilsan Hospital
Locations
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Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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HM-APOLLO-302
Identifier Type: -
Identifier Source: org_study_id
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