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NCT04488978 Clinical Trial

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

Essential Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04488978
Other study ID # AI-C201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 21, 2020
Est. completion date November 9, 2021

Study information
Verified date June 2022
Source Handok Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 440
Est. completion date November 9, 2021
Est. primary completion date November 9, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Irbesartan/Amlodipine
QID

Locations
Country Name City State
Korea, Republic of Yonsei University Health System, Severance 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 The change in MSSBP between baseline and Week8. The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8. Baseline and Week8
Secondary The change in MSSBP between baseline and Week4. Baseline and Week4
Secondary The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8. Baseline and Week4/8
Secondary The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8. Baseline and Week4/8
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