Evaluation of Succinate Metoprolol on heart rate in the stable angina patients
Study identifier:D4022L00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, open label, parallel group, multicentre, phase IV study on the effect of 8 weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients
Medical condition
Angina pectoris
Phase
Phase 4
Healthy volunteers
No
Study drug
Succinate Metoprolol (Betaloc ZOK®)
Sex
All
Actual Enrollment
251
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Sept 2011
Study Completion Date: 01 Sept 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 | Drug: Succinate Metoprolol (Betaloc ZOK®) treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks |
| Experimental: 2 | Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks |
Contacts
Investigators
Principal Investigator
Huo Yong
Department of Cardiology, Peking University First Hospital
