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

Primary Purpose

Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Succinate Metoprolol (Betaloc ZOK®)
Succinate Metoprolol (Betaloc ZOK®)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring angina pectoris, chest pain, heart rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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
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=Σ(STmax×Tisc).
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=Σ(STmax×Tisc).
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.
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.
The Change From Baseline in Total Cholesterol
Difference of change from baseline in TC after 8 weeks treatment between groups.
The Change From Baseline in Fasting Plasma Glucose
Difference of change from baseline in FPG after 8 weeks treatment between groups.
The Change From Baseline in Triglycerides
Difference of change from baseline in TG after 8 weeks treatment between groups.

Full Information

First Posted
September 30, 2010
Last Updated
August 26, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01213173
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
angina pectoris, chest pain, heart rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Succinate Metoprolol (Betaloc ZOK®)
Intervention Description
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
Intervention Name(s)
Succinate Metoprolol (Betaloc ZOK®)
Intervention Description
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
Primary Outcome Measure Information:
Title
The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
Description
Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.
Time Frame
After 8 weeks treatment in the study
Secondary Outcome Measure Information:
Title
The Impact on 24-hr Average Heart Rate From Baseline Within Groups
Description
Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.
Time Frame
After 8 weeks treatment in the study
Title
The Different Impact on 24-hr Average Heart Rate Between Two Groups
Description
Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.
Time Frame
After 2 weeks treatment in the study
Title
The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups
Description
Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.
Time Frame
After 2 weeks treatment in the study
Title
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Description
Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups
Time Frame
After 2 weeks treatment
Title
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Description
Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups
Time Frame
After 8 weeks treatment
Title
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Description
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=Σ(STmax×Tisc).
Time Frame
After 2 weeks treatment
Title
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Description
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).
Time Frame
After 8 weeks treatment
Title
The Difference of Change From Baseline in Angina Frequency Between Groups
Description
Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.
Time Frame
After 2 weeks treatment
Title
The Difference of Change From Baseline in Angina Frequency Between Groups
Description
Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.
Time Frame
After 8 weeks treatment
Title
The Change From Baseline in Total Cholesterol
Description
Difference of change from baseline in TC after 8 weeks treatment between groups.
Time Frame
After 8 weeks treatment
Title
The Change From Baseline in Fasting Plasma Glucose
Description
Difference of change from baseline in FPG after 8 weeks treatment between groups.
Time Frame
After 8 weeks treatment
Title
The Change From Baseline in Triglycerides
Description
Difference of change from baseline in TG after 8 weeks treatment between groups.
Time Frame
After 8 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huo Yong
Organizational Affiliation
Department of Cardiology, Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Lin
Organizational Affiliation
Astrazeneca China
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Tangshan
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Jingzhou
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Tianjing
Country
China

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=331&filename=CSR-D4022L00008.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=331&filename=CSR-D4022L00008.pdf
Description
CSR-D4022L00008.pdf

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

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