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Completed

NCT Number: NCT02916602

A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

A phase 3 study to evaluate efficacy and safety of HCP1401

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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 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hypertension patient who satisfied below condition at Visit 1.
  • patient who takes antihypertensive drug
  • 140mmHg <= sitSBP <= 200mmHg
  • patient who doesn't take antihypertensive drug
  • 160mmHg <= sitSBP <= 200mmHg
  • 140mmHg <= sitSBP <= 200mmHg at Visit 2

Exclusion criteria

  • Patient who have received 4 or more antihypertensive drug
  • Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
  • Patient with sitDBP >= 120mmHg at Visit 2
  • Patient with secondary hypertension

Treatment and study plan

HCP1401

Drug

amlodipine, Losartan, Chlorthalidone FDC

Other names: amlodipine, Losartan, Chlorthalidone

HCP0605

Drug

amlodipine, Losartan FDC

Other names: amlodipine, Losartan

Primary outcomes

  1. Change from baseline in sitting systolic blood pressure at week 8

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline in sitting diastolic blood pressure at week 2 and week 8

    Time frame: 2 weeks and 8 weeks

  2. Change from baseline in sitting systolic blood pressure at week 2

    Time frame: 2 weeks

  3. Proportion of subjects achieving Blood Pressure control

    Time frame: 2 weeks and 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2016
Registry last updated
Oct 20, 2016

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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