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

June 28, 2022 updated by: Handok Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Irbesartan low/Amlodipine low
Irbesartan low & Amlodipine low, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
EXPERIMENTAL: Irbesartan low/Amlodipine high
Irbesartan low & Amlodipine high, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
EXPERIMENTAL: Irbesartan high/Amlodipine low
Irbesartan high & Amlodipine low, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
EXPERIMENTAL: Irbesartan high/Amlodipine high
Irbesartan high & Amlodipine high, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
ACTIVE_COMPARATOR: Amlodipine low
Amlodipine low, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
ACTIVE_COMPARATOR: Amlodipine high
Amlodipine high, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
ACTIVE_COMPARATOR: Irbesartan low
Irbesartan low, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID
ACTIVE_COMPARATOR: Irbesartan high
Irbesartan high, once daily for 8 weeks
Drug: Irbesartan/Amlodipine
QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week8

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in MSSBP between baseline and Week4.
Time Frame: Baseline and Week4
Baseline and Week4
The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
Time Frame: Baseline and Week4/8
Baseline and Week4/8
The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
Time Frame: Baseline and Week4/8
Baseline and Week4/8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 21, 2020

Primary Completion (ACTUAL)

November 9, 2021

Study Completion (ACTUAL)

November 9, 2021

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-C201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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