A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
NCT ID: NCT05450601
Last Updated: 2024-03-05
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
2022-09-01
2023-12-11
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
HCP2102
HCP2102-1
Take once daily for 2 weeks orally
HPP2104-1
Placebo drug. Take once daily for 2 weeks orally
HCP2102-2
Take once daily for 6 weeks orally
HPP2104-2
Placebo drug. Take once daily for 6 weeks orally
Active Comparator
RLD2106
RLD2106-1
Take once daily for 2 weeks orally
HPP2103-1
Placebo drug. Take once daily for 2 weeks orally
RLD2106-2
Take once daily for 6 weeks orally
HPP2103-2
Placebo drug. Take once daily for 6 weeks orally
Interventions
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HCP2102-1
Take once daily for 2 weeks orally
HPP2104-1
Placebo drug. Take once daily for 2 weeks orally
HCP2102-2
Take once daily for 6 weeks orally
HPP2104-2
Placebo drug. Take once daily for 6 weeks orally
RLD2106-1
Take once daily for 2 weeks orally
HPP2103-1
Placebo drug. Take once daily for 2 weeks orally
RLD2106-2
Take once daily for 6 weeks orally
HPP2103-2
Placebo drug. Take once daily for 6 weeks orally
Eligibility Criteria
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Inclusion Criteria
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. 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
4. Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
Exclusion Criteria
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
3. Secondary hypertension 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. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
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(Ca ≥ 10.5mg/dL)
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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Locations
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Kyung Hee University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-ALCH-302
Identifier Type: -
Identifier Source: org_study_id
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