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

Condition(s) targeted: Angina Pectoris

Intervention: Succinate Metoprolol (Betaloc ZOK®) (Drug); Succinate Metoprolol (Betaloc ZOK®) (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Huo Yong, Principal Investigator, Affiliation: Department of Cardiology, Peking University First Hospital
Helen Lin, Study Director, Affiliation: Astrazeneca China

Overall contact:
AstraZeneca Clinical Study Information, Phone: 86 21 52564555, Email: Huafei.Li@astrazeneca.com

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.

Official title: A Randomised, Open Label, Parallel Group, Multicentre, Phase IV Study on the Effect of 8 Weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on Heart Rate in the Stable Angina Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To investigate the impact on 24-hr average heart rate between two groups (Betaloc ZOK® 95mg vs. 190mg)

Secondary outcome:

To investigate the impact on 24-hr average heart rate from baseline within groups

To investigate the different impact on 24-hr average heart rate between two groups

To investigate the different impact on 24-hr average heart rate from baseline within groups

To investigate the proportion of patients with resting heart rate controlled to ≤60bpm between groups .

To investigate the proportion of patients with resting heart rate controlled to ≤60bpm between groups .

To evaluate the difference of change from baseline in total ischemic burden between groups .

To evaluate the difference of change from baseline in total ischemic burden between groups .

To evaluate the difference of change from baseline in angina frequency between groups .

To evaluate the difference of change from baseline in angina frequency between groups .

To observe the numbers of Discontinuation of Investigational Product due to Adverse Events

To observe the numbers of Discontinuation of Investigational Product due to Serious adverse events

To explore the change from baseline in Total cholesterol.

To explore the change from baseline in Fasting plasma glucose.

To explore the change from baseline in Triglycerides.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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)

AstraZeneca Clinical Study Information, Phone: 86 21 52564555, Email: Huafei.Li@astrazeneca.com

Starting date: October 2010
Last updated: September 30, 2010