Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: metoprolol succinate prolonged-release tablet and felodipine

• Registration Number: NCT00861016
• Lead Sponsor: AstraZeneca

Brief Summary

This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with mild to moderate essential hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-04
• Study Completion: 2006-05
• Status Verified: 2009-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Last Update Submitted: 2009-03-12
• Study First Posted: 2009-03-13
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Provision of written informed consent
• Newly diagnosed essential hypertension who have not received anti- hypertensive treatment, or patients without antihypertensive medication in two weeks before screening, 90mmHg<SiDBP <110mmHg and SiSBP <180mmHg.

Exclusion Criteria

• Known or suspected secondary hypertension
• Resting HR is < 55bpm.
• Sick sinus syndrome
• Atrioventricular block of first degree (with P-R>0.24seconds), or second or third degree

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	metoprolol succinate prolonged-release tablet and felodipine	The patients with mild to moderate essential hypertension

Primary Outcome Measures

Name	Time	Method
Percent of subjects reaching blood pressure target at wk 8 after metoprolol succinate prolonged release tablet treatment, and magnitude of systolic and diastolic blood pressure reduction from baseline among subjects who reached target (below 140/90mmHg).	Day -7- -1, Day1, Day 28, Day 56,Day 84

Secondary Outcome Measures

Name	Time	Method
The magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects at week 8 after metoprolol succinate prolonged release tablet treatment.	Day -7- -1, Day1, Day 28, Day 56,Day 84
The percentage of subjects reaching blood pressure target at week 4, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target	Day -7- -1, Day1, Day 28, Day 56,Day 84
The percentage of subjects reaching blood pressure target at week 12, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target	Day -7- -1, Day1, Day 28, Day 56,Day 84