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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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High Blood Pressure (Hypertension).

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Metoprolol Succinate + Hydrochlorothiazide

Group Type EXPERIMENTAL

Metoprolol Succinate

Intervention Type DRUG

Hydrochlorothiazide

Intervention Type DRUG

2

Metoprolol Succinate

Group Type ACTIVE_COMPARATOR

Metoprolol Succinate

Intervention Type DRUG

3

Hydrochlorothiazide

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Interventions

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Metoprolol Succinate

Intervention Type DRUG

Hydrochlorothiazide

Intervention Type DRUG

Other Intervention Names

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TOPROL-XL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No