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

Phase 3

Completed

• Conditions: High Blood Pressure (Hypertension).
• Interventions: Drug: Metoprolol Succinate; Drug: Hydrochlorothiazide

• Registration Number: NCT00642096
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Metoprolol Succinate	Metoprolol Succinate + Hydrochlorothiazide
1	Hydrochlorothiazide	Metoprolol Succinate + Hydrochlorothiazide
2	Metoprolol Succinate	Metoprolol Succinate
3	Hydrochlorothiazide	Hydrochlorothiazide

Primary Outcome Measures

Name	Time	Method
Change in trough sitting diastolic blood pressure	3 readings determined at 8 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
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