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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Succinate Metoprolol (Betaloc ZOK®)

Intervention Type DRUG

treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks

2

Group Type EXPERIMENTAL

Succinate Metoprolol (Betaloc ZOK®)

Intervention Type DRUG

Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks

Interventions

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Succinate Metoprolol (Betaloc ZOK®)

treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks

Intervention Type DRUG

Succinate Metoprolol (Betaloc ZOK®)

Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No