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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Succinate Metoprolol (Betaloc ZOK®) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Different Impact on 24-hr Average Heart Rate Between Two Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huo Yong | Department of Cardiology, Peking University First Hospital | Principal Investigator |
| Helen Lin | Astrazeneca China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D4022L00008.pdf | View source |
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Safety population- patients who received at least 1 dose of investigational product. During initial 1 week run-in period subjects were treated with 47.5mg Betaloc ZOK®. Patients started to take investigational product before randomization therefore, number of subjects in Safety population (274) is greater than number of randomized and treated (251)
Safety Population is divided according to the actual dosage received by the patient, not the randomization. The patient will be high-dose group if the highest dose ever used is above 95mg; otherwise (if the highest dose ever used is equal to or lower than 95 mg) he/she will be low-dose group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator | lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks |
| FG001 | Experimental | lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks |
| BG001 | Experimental | lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Mean | Standard Deviation | Bpm | After 8 weeks treatment in the study |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator | lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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The sample size was insufficient for the secondary endpoints. Besides, the treatment prior to study did not correlate well with 47.5 mg metoprolol succinate, but with some higher dose. last the quality control of the study needs further improvement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Succinate Metoprolol (Betaloc ZOK®) | Drug | 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 |
|
Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment. |
| After 2 weeks treatment in the study |
| 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 |
| 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 |
| 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 |
| 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). | After 2 weeks treatment |
| 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). | After 8 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 2 weeks treatment. | 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. | After 8 weeks treatment |
| The Change From Baseline in Total Cholesterol | Difference of change from baseline in TC after 8 weeks treatment between groups. | After 8 weeks treatment |
| 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 |
| The Change From Baseline in Triglycerides | Difference of change from baseline in TG after 8 weeks treatment between groups. | After 8 weeks treatment |
| Guangzhou |
| Guangdong |
| China |
| Research Site | Tangshan | Hebei | China |
| Research Site | Zhengzhou | Henan | China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Jingzhou | Liaoning | China |
| Research Site | Shenyang | Liaoning | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Taiyuan | Shanxi | China |
| Research Site | Tianjing | China |
| Withdrawal by Subject |
|
| Incorrect Enrollment |
|
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Arm 2 - Experimental | 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 |
|
|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | Bpm | After 8 weeks treatment in the study |
|
|
|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Mean | Standard Deviation | Bpm | After 2 weeks treatment in the study |
|
|
|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | Bpm | After 2 weeks treatment in the study |
|
|
|
| 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 | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Number | Participants | After 2 weeks treatment |
|
|
|
| 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 | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Number | Participants | After 8 weeks treatment |
|
|
|
| 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=Σ(STmax×Tisc). | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | mm*min | After 2 weeks treatment |
|
|
|
| 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=Σ(STmax×Tisc). | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | mm*min | After 8 weeks treatment |
|
|
|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | Attacks per week | After 2 weeks treatment |
|
|
|
| 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. | ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | Attacks per week | After 8 weeks treatment |
|
|
|
| Secondary | The Change From Baseline in Total Cholesterol | Difference of change from baseline in TC after 8 weeks treatment between groups. | All subjects who received at least one dose of randomized investigational product was included in the safety population. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | mmol/L | After 8 weeks treatment |
|
|
|
| Secondary | The Change From Baseline in Fasting Plasma Glucose | Difference of change from baseline in FPG after 8 weeks treatment between groups. | All subjects who received at least one dose of randomized investigational product was included in the safety population. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | mmol/L | After 8 weeks treatment |
|
|
|
| Secondary | The Change From Baseline in Triglycerides | Difference of change from baseline in TG after 8 weeks treatment between groups. | All subjects who received at least one dose of randomized investigational product was included in the safety population. | Posted | Dec 2013 | Least Squares Mean | 95% Confidence Interval | mmol/L | After 8 weeks treatment |
|
|
|
| 1 |
| 139 |
| 0 |
| 139 |
| EG001 | Experimental | lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks | 3 | 112 | 0 | 112 |
| Genital neoplasm malignant female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| angina unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |