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

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Irbesartan/Amlodipine

• Registration Number: NCT04488978
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Irbesartan low/Amlodipine high	Irbesartan/Amlodipine	Irbesartan low \& Amlodipine high, once daily for 8 weeks
Irbesartan high/Amlodipine high	Irbesartan/Amlodipine	Irbesartan high \& Amlodipine high, once daily for 8 weeks
Irbesartan low/Amlodipine low	Irbesartan/Amlodipine	Irbesartan low \& Amlodipine low, once daily for 8 weeks
Amlodipine low	Irbesartan/Amlodipine	Amlodipine low, once daily for 8 weeks
Irbesartan low	Irbesartan/Amlodipine	Irbesartan low, once daily for 8 weeks
Irbesartan high/Amlodipine low	Irbesartan/Amlodipine	Irbesartan high \& Amlodipine low, once daily for 8 weeks
Amlodipine high	Irbesartan/Amlodipine	Amlodipine high, once daily for 8 weeks
Irbesartan high	Irbesartan/Amlodipine	Irbesartan high, once daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
The change in MSSBP between baseline and Week8.	Baseline and Week8	The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of