Phase 4
N=251
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
Angina Pectoris
Bottom Line
View on ClinicalTrials.gov: NCT01213173 ↗Enrolled (actual)
251
Serious AEs
1.6%
Results posted
Aug 2013
Primary outcome: Primary: The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) — 71.4; 70.9; 70.9; 68.6 Bpm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Succinate Metoprolol (Betaloc ZOK®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) |
71.4; 70.9; 70.9; 68.6 | — |
| SECONDARY The Impact on 24-hr Average Heart Rate From Baseline Within Groups |
-0.6244; -2.9858 | — |
| SECONDARY The Different Impact on 24-hr Average Heart Rate Between Two Groups |
70.6; 69.2 | — |
| SECONDARY The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups |
-0.4938; -2.1383 | — |
| SECONDARY The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups |
28; 46 | — |
| SECONDARY The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups |
28; 46 | — |
| SECONDARY The Difference of Change From Baseline in Total Ischemic Burden Between Groups |
22.2905; -7.6586 | — |
| SECONDARY The Difference of Change From Baseline in Total Ischemic Burden Between Groups |
22.2905; -7.6586 | — |
| SECONDARY The Difference of Change From Baseline in Angina Frequency Between Groups |
-0.3930; -0.4453 | — |
| SECONDARY The Difference of Change From Baseline in Angina Frequency Between Groups |
-0.3930; -0.4453 | — |
| SECONDARY The Change From Baseline in Total Cholesterol |
-0.0505; 0.5825 | — |
| SECONDARY The Change From Baseline in Fasting Plasma Glucose |
0.3844; 0.2487 | — |
| SECONDARY The Change From Baseline in Triglycerides |
0.1295; 0.0937 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01213173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.