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

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study Start: 2010-10
• Study First Posted: 2010-10-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-11-08
• Results First Submitted QC: 2013-07-02
• Results First Posted: 2013-08-26
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-09-05

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.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tianjing, China