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NCT05475665 Clinical Trial

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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05475665
Other study ID # HD-AI-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 14, 2022
Est. completion date June 13, 2023

Study information
Verified date August 2023
Source Handok Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 157
Est. completion date June 13, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 with symptom - Other exclusion applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Irbesartan/Amlodipine
Irbesartan/Amlodipine once daily for 8 weeks
• Irbesartan
Irbesartan once daily for 8 weeks

Locations
Country Name City State
Korea, Republic of Hanyang University Seoul Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in mean sitting systolic blood pressure (mmHg) Week 8
Secondary Change form baseline in mean sitting systolic blood pressure (mmHg) Week 4
Secondary Change form baseline in mean sitting diastolic blood pressure (mmHg) Week 4, 8
Secondary Responder rate Week 4, 8
Secondary Target blood pressure reach rate Week 4, 8
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