Clinical trial NCT01213173: Evaluation of Succinate Metoprolol 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angina Pectoris
Keywords: angina pectoris
chest pain
heart rate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
timeFrame: After 8 weeks treatment in the study
Secondary outcomes:
measure: The Impact on 24-hr Average Heart Rate From Baseline Within Groups
timeFrame: After 8 weeks treatment in the study
measure: The Different Impact on 24-hr Average Heart Rate Between Two Groups
timeFrame: After 2 weeks treatment in the study
measure: The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups
timeFrame: After 2 weeks treatment in the study
measure: The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
timeFrame: After 2 weeks treatment
measure: The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
timeFrame: After 8 weeks treatment
measure: The Difference of Change From Baseline in Total Ischemic Burden Between Groups
timeFrame: After 2 weeks treatment
measure: The Difference of Change From Baseline in Total Ischemic Burden Between Groups
timeFrame: After 8 weeks treatment
measure: The Difference of Change From Baseline in Angina Frequency Between Groups
timeFrame: After 2 weeks treatment
measure: The Difference of Change From Baseline in Angina Frequency Between Groups
timeFrame: After 8 weeks treatment
measure: The Change From Baseline in Total Cholesterol
timeFrame: After 8 weeks treatment
measure: The Change From Baseline in Fasting Plasma Glucose
timeFrame: After 8 weeks treatment
measure: The Change From Baseline in Triglycerides
timeFrame: After 8 weeks treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Tangshan
country: China
facility: Research Site
state: Hebei
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Jingzhou
country: China
facility: Research Site
state: Liaoning
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Tianjing
country: China
facility: Research Site
Study officials:
affiliation: Department of Cardiology, Peking University First Hospital
name: Huo Yong
role: PRINCIPAL_INVESTIGATOR
affiliation: Astrazeneca China
name: Helen Lin
role: STUDY_DIRECTOR
References: