Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)