Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.

Official Title
-----------------
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Amlodipine plus Losartan
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient) Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg) Exclusion Criteria: mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers Secondary hypertensive patient or suspected to be Uncontrolled diabetes mellitus patients Severe heart disease or severe neurovascular disease Known as severe or malignant retinopathy Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST) History of malignancy tumor History of autoimmune disease History of alcohol or drug abuse Positive to pregnancy test, nursing mother, has an intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with othe reason

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amlodipine/losartan 5/50mg<br> | Drug: Amlodipine plus Losartan<br>* amlodipine/losartan 5/50mg q.d.<br>* Other names: Amosartan;|
| Active Comparator: amlodipine 5mg<br> | Drug: Amlodipine<br>* amlodipine 5mg q.d.<br>* Other names: Amodpine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure |  | Week 4 | 
| Change from baseline in mean sitting systolic blood pressure |  | Week 4, 8 | 
| Responder rate |  | Week 4, 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amlodipine, Losartan, hypertension