8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Official Title
-----------------
An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.

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

Intervention / Treatment
-----------------
* Drug: Valsartan + amlodipine
* Drug: Valsartan + HCTZ
* Drug: Amlodipine + HCTZ
* Drug: Valsartan + amlodipine + HCTZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg). Exclusion Criteria: Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1. Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1. Patients on four or more antihypertensive drugs at Visit 1. Arm circumference > 42 cm for patients participating in ABPM. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan + amlodipine|nan|
|Drug: Valsartan + HCTZ|nan|
|Drug: Amlodipine + HCTZ|nan|
|Drug: Valsartan + amlodipine + HCTZ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline systolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure less than 140/90 mmHg after 8 weeks |  |  | 
| Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks |  |  | 
| Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements |  |  | 
| Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, valsartan, amlodipine, HCTZ