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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Angina Pectoris

Treatments: Drug: Succinate Metoprolol (Betaloc ZOK®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01213173

D4022L00008

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

251 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Succinate Metoprolol (Betaloc ZOK®)

Drug: Succinate Metoprolol (Betaloc ZOK®)

2

Experimental group

Treatment:

Drug: Succinate Metoprolol (Betaloc ZOK®)

Drug: Succinate Metoprolol (Betaloc ZOK®)