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OpenTrials
Completed

NCT Number: NCT05476354

Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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 on screening
  • Signed informed consent
  • Patients with Essential Hypertension
  • Other inclusion applied

Exclusion criteria

  • Orthostatic hypotension
  • Other exclusion applied

Treatment and study plan

Irbesartan/Amlodipine low

Drug

Irbesartan/Amlodipine low once daily for 8 weeks

Irbesartan/Amlodipine high

Drug

Irbesartan/Amlodipine high once daily for 8 weeks

Irbesartan

Drug

Irbesartan once daily for 8 weeks

Primary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week8

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure(mmHg)

    Time frame: Week 4

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

    Time frame: Week 4,8

  3. Responder rate

    Time frame: Week 4,8

  4. Target blood pressure reach rate

    Time frame: Week 4,8

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Aug 18, 2023

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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