Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension

Conditions
-----------------
Hypertension, Blood Pressure, High

Intervention / Treatment
-----------------
* Drug: Ramipril and hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment. Exclusion Criteria: Inability to discontinue all prior antihypertensive medications Heart failure History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm Liver or kidney disease Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis Allergy or reactions to certain medications used to treat high blood pressure Other protocol-defined inclusion and exclusion criteria apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: Ramipril and hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily. |  |  | 
| Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily. |  |  | 
| Compare the effect on the sitting and standing blood pressure among all treatment groups. |  |  | 
| Compare the safety of each medication regimen stated above. |  |  | 
| Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diuretic, Hypertension, High Blood Pressure, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring