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Completed

NCT Number: NCT04959305

A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, parallel, phase 2 study to explore the dose of HCP1803 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 2

Primary location

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions
  • 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 mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
  • Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 2

Exclusion criteria

  • Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  • Orthostatic hypotension with symptoms within 3 months prior to 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
  • Moderate or malignant retinopathy
  • Clinically significant hematological finding
  • Severe renal diseases (eGFR<30mL/min/1.73m2)
  • Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
  • 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 other reason

Treatment and study plan

HCP1803-3

Drug

Take it once daily for 8 weeks orally.

RLD2003

Drug

Take it once daily for 8 weeks orally.

RLD2004

Drug

Take it once daily for 8 weeks orally.

RLD2005

Drug

Take it once daily for 8 weeks orally.

HPP2003-3

Drug

Placebo drug. Take it once daily for 8 weeks orally.

HPP2005

Drug

Placebo drug. Take it once daily for 8 weeks orally.

Primary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. Change from baseline in sitting systolic blood pressure

    Time frame: baseline, 4 weeks

  2. Change from baseline in sitting distolic blood pressure

    Time frame: baseline, 4 weeks, 8 weeks

  3. Proportion of subjects achieving blood pressure control

    Time frame: 4 weeks, 8 weeks

  4. Proportion of responder

    Time frame: baseline, 4 weeks, 8 weeks

  5. Change from baseline in pulse pressure(sitSBP - sitDBP)

    Time frame: baseline, 4 weeks, 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel, Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension

Acronym: HM_APOLLO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
Jul 14, 2022

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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