Status:
COMPLETED
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
Lead Sponsor:
AstraZeneca
Conditions:
Angina Pectoris
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Chinese patients
- Heart rate ≥ 65bpm
- Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
- With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;
- Has been on beta-blockers for at least 4 weeks\*, on the dose equivalent to Betaloc ZOK® 23.75-47.5mg/day.
Exclusion
- Acute myocardial infarction within 6 months
- Unstable angina or Prinzmetal's angina
- II degree of AV block or greater
- Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
- Significant renal impairment (serum creatinine \> 2.0 mg/dL)
- Serum Alanine Aminotransferase or Aspartate Aminotransferase \> 3 x upper limit of reference range
- Serum potassium \< 3.0 mEq/L
- Serum sodium ≤ 130 mEq/L
- Acute or chronic hepatitis or cirrhosis (clinical diagnosis)
- Uncontrolled hyperthyroidism (clinical diagnosis)
- Systolic blood pressure ≥ 180 mmHg, or \< 100mmHg at enrolment
- Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01213173
Start Date
October 1 2010
End Date
September 1 2011
Last Update
September 5 2014
Active Locations (10)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Guangzhou, Guangdong, China
3
Research Site
Tangshan, Hebei, China
4
Research Site
Zhengzhou, Henan, China