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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: High Blood Pressure (Hypertension).

Treatments: Drug: Metoprolol Succinate; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642096

D4026C00001

Details and patient eligibility

About

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.

Enrollment: 1,900 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,900 participants in 3 patient groups

1

Experimental group

Description:

Metoprolol Succinate + Hydrochlorothiazide

Treatment:

Drug: Hydrochlorothiazide

Drug: Metoprolol Succinate

2

Active Comparator group

Description:

Metoprolol Succinate

Treatment:

Drug: Metoprolol Succinate

3

Active Comparator group

Description:

Hydrochlorothiazide

Treatment:

Drug: Hydrochlorothiazide