Factorial Study of Metoprolol Succinate TOPROL-XL (324A)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.

Official Title
-----------------
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.

Conditions
-----------------
High Blood Pressure (Hypertension).

Intervention / Treatment
-----------------
* Drug: Metoprolol Succinate
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diastolic blood pressure between 95 and 114 mm at screening and start of treatment Exclusion Criteria: Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism Systolic blood pressure greater or equal to 180 mm Hg at start of trial

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metoprolol Succinate + Hydrochlorothiazide | Drug: Metoprolol Succinate<br> <br> * Other names: TOPROL-XL;Drug: Hydrochlorothiazide<br> <br> |
| Active Comparator: 2<br>Metoprolol Succinate | Drug: Metoprolol Succinate<br> <br> * Other names: TOPROL-XL;|
| Active Comparator: 3<br>Hydrochlorothiazide | Drug: Hydrochlorothiazide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trough sitting diastolic blood pressure |  | 3 readings determined at 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in trough Sitting Systolic Blood pressure |  | 3 readings determined at 8 weeks after treatment | 
| change in trough Standing Systolic Blood Pressure |  | 6 readings determined at 8 weeks after treatment | 
| change in trough standing diastolic blood pressure |  | 6 readings determined at 8 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High blood pressure, hypertension, (TOPROL-XL), metoprolol succinate, hydrochlorothiazide