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

Phase 4

Completed

Conditions: Angina Pectoris

Interventions: Drug: Succinate Metoprolol (Betaloc ZOK®)

Registration Number: NCT01213173

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 251

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Succinate Metoprolol (Betaloc ZOK®)	-
2	Succinate Metoprolol (Betaloc ZOK®)	-

Primary Outcome Measures

Name	Time	Method
The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)	After 8 weeks treatment in the study	Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.

Secondary Outcome Measures

Name	Time	Method
The Impact on 24-hr Average Heart Rate From Baseline Within Groups	After 8 weeks treatment in the study	Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.
The Different Impact on 24-hr Average Heart Rate Between Two Groups	After 2 weeks treatment in the study	Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.
The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups	After 2 weeks treatment in the study	Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups	After 8 weeks treatment	Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups
The Difference of Change From Baseline in Total Ischemic Burden Between Groups	After 8 weeks treatment	Difference in change from baseline in TIB between two groups after 8 weeks treatment. Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc).
The Difference of Change From Baseline in Angina Frequency Between Groups	After 8 weeks treatment	Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.
The Change From Baseline in Total Cholesterol	After 8 weeks treatment	Difference of change from baseline in TC after 8 weeks treatment between groups.
The Change From Baseline in Fasting Plasma Glucose	After 8 weeks treatment	Difference of change from baseline in FPG after 8 weeks treatment between groups.
The Change From Baseline in Triglycerides	After 8 weeks treatment	Difference of change from baseline in TG after 8 weeks treatment between groups.