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

Handok Inc.440 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

440

Conditions

Essential Hypertension

Interventions

Irbesartan/AmlodipineDRUG

QID

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week8

Secondary Outcomes

The change in MSSBP between baseline and Week4.

Time frame: Baseline and Week4

The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.

Time frame: 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

Data from ClinicalTrials.gov

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