An Open-Label, Non-Comparative, Multi-Centre Study to Evaluate the Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet (Betaloc Zok) in Patients With Mild to Moderate Essential Hypertension

AstraZeneca0 sites310 target enrollmentOctober 2005

ConditionsHypertension

Interventionsmetoprolol succinate prolonged-release tablet and felodipine

Drugsmetoprolol succinate prolonged-release tablet and felodipine

Overview

Phase: Phase 4
Intervention: metoprolol succinate prolonged-release tablet and felodipine
Conditions: Hypertension
Sponsor: AstraZeneca
Enrollment: 310
Primary Endpoint: 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).
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

May 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

The patients with mild to moderate essential hypertension

Intervention: metoprolol succinate prolonged-release tablet and felodipine

Outcomes

Primary Outcomes

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).

Time Frame: Day -7- -1, Day1, Day 28, Day 56,Day 84

Secondary Outcomes

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)