Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Official Title
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An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: valsartan + amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg. Exclusion Criteria: History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics Inability to stop all prior blood pressure medications safely Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina Type 1 diabetes Poorly controlled Type 2 diabetes History of heart failure Arrhythmia Significant valvular heart disease Active gout History of autoimmune diseases History of multiple drug allergies Liver disease Pancreatic injury within 1 year of screening Evidence of kidney impairment or history of dialysis Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed Pregnant or nursing (lactating) women History of malignancy of any organ system within the past five years Any severe, life-threatening disease within the past five years History of drug or alcohol abuse within the last 2 years. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan + amlodipine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP at week 4 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline MSSBP after 2 and 8 weeks of treatment |  |  | 
| Change from baseline MSDBP after 2, 4 and 8 weeks of treatment |  |  | 
| Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment |  |  | 
| Evaluation of safety and tolerability after 8 weeks of treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Venous pressure, Systolic pressure, Diastolic pressure, Pulse pressure