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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00861016
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: metoprolol succinate prolonged-release tablet and felodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : May 2006


Arm Intervention/treatment
Experimental: 1
The patients with mild to moderate essential hypertension
Drug: metoprolol 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
Other Name: Betaloc ZOK and Plendil




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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<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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861016


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Lisheng Liu BeiJing Hypertension League
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Responsible Party: Marco Avila, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00861016    
Other Study ID Numbers: D4025L00006
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Post marketing study
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Felodipine
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents