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
Overview
- Phase
- Phase 2
- Intervention
- Irbesartan/Amlodipine
- Conditions
- Essential Hypertension
- Sponsor
- Handok Inc.
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- The change in MSSBP between baseline and Week8.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Irbesartan low/Amlodipine low
Irbesartan low \& Amlodipine low, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Irbesartan low/Amlodipine high
Irbesartan low \& Amlodipine high, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Irbesartan high/Amlodipine low
Irbesartan high \& Amlodipine low, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Irbesartan high/Amlodipine high
Irbesartan high \& Amlodipine high, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Amlodipine low
Amlodipine low, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Amlodipine high
Amlodipine high, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Irbesartan low
Irbesartan low, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Irbesartan high
Irbesartan high, once daily for 8 weeks
Intervention: Irbesartan/Amlodipine
Outcomes
Primary Outcomes
The change in MSSBP between baseline and Week8.
Time Frame: Baseline and Week8
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
Secondary Outcomes
- 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)