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

August 15, 2023 updated by: Handok Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 3

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Irbesartan
Drug: Irbesartan
Irbesartan once daily for 8 weeks
Experimental: Irbesartan/Amlodipine low
Drug: Irbesartan/Amlodipine low
Irbesartan/Amlodipine low once daily for 8 weeks
Experimental: Irbesartan/Amlodipine high
Drug: Irbesartan/Amlodipine high
Irbesartan/Amlodipine high once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: Week8
Week8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: Week 4
Week 4
2.Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame: Week 4,8
Week 4,8
Responder rate
Time Frame: Week 4,8
Week 4,8
Target blood pressure reach rate
Time Frame: Week 4,8
Week 4,8

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)

July 5, 2022

Primary Completion (Actual)

April 3, 2023

Study Completion (Actual)

June 13, 2023

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-AI-301

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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