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

Angina Pectoris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213173
• Other study ID #: D4022L00008
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2010
• Last updated: August 26, 2014
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Guangzhou	Guangdong
China	Research Site	Jingzhou	Liaoning
China	Research Site	Nanjing	Jiangsu
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tangshan	Hebei
China	Research Site	Tianjing
China	Research Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)	Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.	After 8 weeks treatment in the study	No
Secondary	The Impact on 24-hr Average Heart Rate From Baseline Within Groups	Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.	After 8 weeks treatment in the study	No
Secondary	The Different Impact on 24-hr Average Heart Rate Between Two Groups	Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.	After 2 weeks treatment in the study	No
Secondary	The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups	Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.	After 2 weeks treatment in the study	No
Secondary	The Proportion of Patients With Resting Heart Rate Controlled to =60bpm Between Groups	Difference in proportions of patients who had resting heart rate controlled to =60 bpm after 2 weeks treatment between groups	After 2 weeks treatment	No
Secondary	The Proportion of Patients With Resting Heart Rate Controlled to =60bpm Between Groups	Difference in proportions of patients who had resting heart rate controlled to =60 bpm after 8 weeks treatment between groups	After 8 weeks treatment	No
Secondary	The Difference of Change From Baseline in Total Ischemic Burden Between Groups	Difference in change from baseline in TIB between two groups after 2 weeks treatment.; Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=S(STmax×Tisc).	After 2 weeks treatment	No
Secondary	The Difference of Change From Baseline in Total Ischemic Burden Between Groups	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=S(STmax×Tisc).	After 8 weeks treatment	No
Secondary	The Difference of Change From Baseline in Angina Frequency Between Groups	Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.	After 2 weeks treatment	No
Secondary	The Difference of Change From Baseline in Angina Frequency Between Groups	Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.	After 8 weeks treatment	No
Secondary	The Change From Baseline in Total Cholesterol	Difference of change from baseline in TC after 8 weeks treatment between groups.	After 8 weeks treatment	Yes
Secondary	The Change From Baseline in Fasting Plasma Glucose	Difference of change from baseline in FPG after 8 weeks treatment between groups.	After 8 weeks treatment	Yes
Secondary	The Change From Baseline in Triglycerides	Difference of change from baseline in TG after 8 weeks treatment between groups.	After 8 weeks treatment	Yes

External Links

•   Link
•   CSR-D4022L00008.pdf