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
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