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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which irbesartan and amlodipine synergistically lower blood pressure in essential hypertension?
How does the irbesartan/amlodipine combination compare to standard-of-care antihypertensive regimens in terms of efficacy and safety profiles?
Which biomarkers are associated with differential response to irbesartan, amlodipine, or their combination in essential hypertension patients?
What are the potential adverse event profiles and management strategies for combined angiotensin II receptor blocker and calcium channel blocker therapy in NCT04488978?
How do other angiotensin II receptor blockers or calcium channel blockers compare to irbesartan and amlodipine in treating essential hypertension?
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, Severance Hospital🇰🇷Seoul, Korea, Republic of