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Completed

NCT Number: NCT03897868

A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

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

  • Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2

Exclusion criteria

  • Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  • Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
  • Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
  • Patient with secondary hypertension

Treatment and study plan

HCP1803

Drug

HCP1803

Amlodipine

Drug

Amlodipine

Losartan

Drug

Losartan

Placebo

Drug

Placebo

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

    sitSBP/sitDBP < 140/90 mmHg

  4. Proportion of responder

    Time frame: baseline, 4 weeks, 8 weeks

    Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg

  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 Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Acronym: HM_APOLLO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
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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