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

Phase 3CompletedNCT00642096

AstraZeneca1,900 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,900

Conditions

High Blood Pressure (Hypertension).

Interventions

Metoprolol SuccinateDRUG

HydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in trough sitting diastolic blood pressure

Time frame: 3 readings determined at 8 weeks after treatment

Secondary Outcomes

change in trough Sitting Systolic Blood pressure

Time frame: 3 readings determined at 8 weeks after treatment

change in trough Standing Systolic Blood Pressure

Time frame: 6 readings determined at 8 weeks after treatment

change in trough standing diastolic blood pressure

Time frame: 6 readings determined at 8 weeks after treatment

Data from ClinicalTrials.gov

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