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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00861016

Enrollment

310

Registered

2009-03-13

Start date

2005-10-31

Completion date

2006-05-31

Last updated

2009-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Post marketing study

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.

Interventions

DRUGmetoprolol succinate prolonged-release tablet and felodipine

a regimen that starts with metoprolol succinate prolonged-release tablet 47.5mg once daily, orally and allows for dose escalation to 95mg once daily, orally at 4 weeks if not controlled; at week 8 allows for the addition of felodipine sustained release tablet 5mg once daily, orally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026