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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: metoprolol succinate prolonged-release tablet and felodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861016

D4025L00006

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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310 participants in 1 patient group

1

Experimental group

Description:

The patients with mild to moderate essential hypertension

Treatment:

Drug: metoprolol succinate prolonged-release tablet and felodipine