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OpenTrials
Completed

NCT Number: NCT05199129

Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seoul, 03722, South Korea

About this study

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 19 years of age
  • Patients who understands the process of clinical study and voluntarily signs a peer letter
  • Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions
  • Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
  • Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
  • Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg

Exclusion criteria

  • Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
  • Orthostatic hypotension with symptoms within 3months of visit 1
  • Secondary hypertensive 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
  • 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 othe reason

Treatment and study plan

HCP1904-3

Drug

Take once daily for 8 weeks orally

RLD2001-1

Drug

Take once daily for 8 weeks orally

Primary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week 4

  2. Change from baseline in mean sitting diastolic blood pressure(mmHg)

    Time frame: Week 4,8

  3. Change from baseline in mean pulse blood pressure(mmHg)

    Time frame: Week 4,8

  4. Target blood pressure reach rate(%)

    Time frame: Week 4,8

  5. Blood pressure responder rate(%)

    Time frame: Week 4,8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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