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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: metoprolol succinate prolonged-release tablet and felodipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Lisheng Liu, Principal Investigator, Affiliation: BeiJing Hypertension League

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome:

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.

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 - 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

Locations and Contacts

Additional Information

Starting date: October 2005
Last updated: March 12, 2009

Page last updated: August 23, 2015

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