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Completed

NCT Number: NCT00861016

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Betaloc ZOK and Plendil

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).

    Time frame: Day -7- -1, Day1, Day 28, Day 56,Day 84

Secondary outcomes

  1. 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.

    Time frame: Day -7- -1, Day1, Day 28, Day 56,Day 84

  2. 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

    Time frame: Day -7- -1, Day1, Day 28, Day 56,Day 84

  3. 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

    Time frame: Day -7- -1, Day1, Day 28, Day 56,Day 84

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 13, 2009
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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