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

NCT00861016 | Completed Phase 4

• 1 other identifier: D4025L00006
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Post marketing study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

1

EXPERIMENTAL

The patients with mild to moderate essential hypertension

Drug: metoprolol succinate prolonged-release tablet and felodipine

Interventions

metoprolol succinate prolonged-release tablet and felodipine DRUG

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

Also known as: Betaloc ZOK and Plendil

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Hypertension

Interventions

Felodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisheng Liu

  BeiJing Hypertension League

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: October 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: May 1, 2006
• Last Updated: March 13, 2009

Record last verified: 2009-03