A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    246
  • sponsor
    Hanmi Pharmaceutical Company Limited
Updated on 4 October 2022
hypertension
essential hypertension

Summary

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Details
Condition Hypertension
Treatment HCP2102-1, HPP2104-1, HCP2102-2, HPP2104-2, RLD2106-1, HPP2103-1, RLD2106-2, HPP2103-2
Clinical Study IdentifierNCT05450601
SponsorHanmi Pharmaceutical Company Limited
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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