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CompletedNCT00861016Updated Mar 13, 2009

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

A Phase 4 interventional study of metoprolol succinate prolonged-release tablet and felodipine in Hypertension, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-03-13.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
310
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Post marketing study
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 310 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
310 participants (actual)

Study arms

  • Experimental
    1

    The patients with mild to moderate essential hypertension

    Drug: metoprolol succinate prolonged-release tablet and felodipine

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

    Also known as: Betaloc ZOK and Plendil

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00861016
Lead sponsor
AstraZeneca
First posted
Mar 13, 2009
Start date
Oct 2005
Primary completion
Apr 2006
Completion
May 2006
Last update
Mar 13, 2009

Study contacts

Lisheng Liu
principal investigator · BeiJing Hypertension League

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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