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OpenTrials
Completed

NCT Number: NCT04488978

Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension

A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Completed

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are 19 years or older / 75 years or younger on screening
  • Signed informed consent
  • Patients with Essential Hypertension
  • Other inclusion applied

Exclusion criteria

  • Orthostatic hypertension with symptom
  • Other exclusion applied

Treatment and study plan

Irbesartan/Amlodipine

Drug

QID

Primary outcomes

  1. The change in MSSBP between baseline and Week8.

    Time frame: Baseline and Week8

    The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.

Secondary outcomes

  1. The change in MSSBP between baseline and Week4.

    Time frame: Baseline and Week4

  2. The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.

    Time frame: Baseline and Week4/8

  3. The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.

    Time frame: Baseline and Week4/8

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
Jun 30, 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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