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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01213173
First received: September 30, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Drug: Succinate Metoprolol (Betaloc ZOK®)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) [ Time Frame: After 8 weeks treatment in the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 8 weeks treatment in the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 2 weeks treatment in the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 2 weeks treatment in the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: No ]
    Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.

  • The Change From Baseline in Total Cholesterol [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: Yes ]
    Difference of change from baseline in TC after 8 weeks treatment between groups.

  • The Change From Baseline in Fasting Plasma Glucose [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: Yes ]
    Difference of change from baseline in FPG after 8 weeks treatment between groups.

  • The Change From Baseline in Triglycerides [ Time Frame: After 8 weeks treatment ] [ Designated as safety issue: Yes ]
    Difference of change from baseline in TG after 8 weeks treatment between groups.


Enrollment: 251
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Experimental: 2 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213173

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hebei
Research Site
Tangshan, Hebei, China
China, Henan
Research Site
Zhengzhou, Henan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Liaoning
Research Site
Jingzhou, Liaoning, China
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
China
Research Site
Tianjing, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Huo Yong Department of Cardiology, Peking University First Hospital
Study Director: Helen Lin Astrazeneca China
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01213173     History of Changes
Other Study ID Numbers: D4022L00008
Study First Received: September 30, 2010
Results First Received: November 8, 2012
Last Updated: August 26, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
angina pectoris
chest pain
heart rate

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Metoprolol
Metoprolol succinate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014