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Completed

NCT Number: NCT05450601

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

HCP2102-1

Drug

Take once daily for 2 weeks orally

HPP2104-1

Drug

Placebo drug. Take once daily for 2 weeks orally

HCP2102-2

Drug

Take once daily for 6 weeks orally

HPP2104-2

Drug

Placebo drug. Take once daily for 6 weeks orally

RLD2106-1

Drug

Take once daily for 2 weeks orally

HPP2103-1

Drug

Placebo drug. Take once daily for 2 weeks orally

RLD2106-2

Drug

Take once daily for 6 weeks orally

HPP2103-2

Drug

Placebo drug. Take once daily for 6 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 2

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

    Time frame: week 2, 8

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

    Time frame: week 2, 8

  4. Target blood pressure reaching rate(%)

    Time frame: week 2, 8

  5. Blood pressure responder rate(%)

    Time frame: week 2, 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
Mar 5, 2024

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.

Published trials that share one or more normalized conditions with this study.