Trial · NCT01213173
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
NCT01213173, Phase 4, Completed, AstraZeneca; results first posted 2013-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients. Trials, record NCT01213173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01213173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
- NCT number
- NCT01213173
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 251 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Angina Pectoris
- Interventions
- Succinate Metoprolol (Betaloc ZOK®), Succinate Metoprolol (Betaloc ZOK®)
- First posted
- 2010-10-01
- Last updated
- 2014-09-05
- Results first posted
- 2013-08-26
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | After 8 weeks treatment in the study | Difference of the 24-hr average heart rate between two groups after 8 weeks treatment. |
| Secondary | The Impact on 24-hr Average Heart Rate From Baseline Within Groups | After 8 weeks treatment in the study | Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment. |
| Secondary | The Different Impact on 24-hr Average Heart Rate Between Two Groups | After 2 weeks treatment in the study | Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment. |
| Secondary | The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups | After 2 weeks treatment in the study | Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment. |
| Secondary | The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups | After 2 weeks treatment | Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups |
| Secondary | The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups | After 8 weeks treatment | Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups |
| Secondary | The Difference of Change From Baseline in Total Ischemic Burden Between Groups | After 2 weeks treatment | 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). |
| Secondary | The Difference of Change From Baseline in Total Ischemic Burden Between Groups | After 8 weeks treatment | 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). |
| Secondary | The Difference of Change From Baseline in Angina Frequency Between Groups | After 2 weeks treatment | Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment. |
| Secondary | The Difference of Change From Baseline in Angina Frequency Between Groups | After 8 weeks treatment | Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | After 8 weeks treatment in the study | 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. | Bpm | MEAN |
| SECONDARY | The Impact on 24-hr Average Heart Rate From Baseline Within Groups | After 8 weeks treatment in the study | 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. | Bpm | LEAST_SQUARES_MEAN |
| SECONDARY | The Different Impact on 24-hr Average Heart Rate Between Two Groups | After 2 weeks treatment in the study | 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. | Bpm | MEAN |
| SECONDARY | The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups | After 2 weeks treatment in the study | 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. | Bpm | LEAST_SQUARES_MEAN |
| SECONDARY | The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between 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. | Participants | NUMBER |
| SECONDARY | The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between 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. | Participants | NUMBER |
| SECONDARY | The Difference of Change From Baseline in Total Ischemic Burden Between 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. | mm*min | LEAST_SQUARES_MEAN |
| SECONDARY | The Difference of Change From Baseline in Total Ischemic Burden Between 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. | mm*min | LEAST_SQUARES_MEAN |
| SECONDARY | The Difference of Change From Baseline in Angina Frequency Between 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. | Attacks per week | LEAST_SQUARES_MEAN |
| SECONDARY | The Difference of Change From Baseline in Angina Frequency Between 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. | Attacks per week | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | Arm 1 - Active Comparator | Baseline | 71.4 | Standard Deviation 8.02 | Bpm |
| The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | Arm 2 - Experimental | Baseline | 70.9 | Standard Deviation 8.19 | Bpm |
| The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | Arm 1 - Active Comparator | Week 9 | 70.9 | Standard Deviation 8.71 | Bpm |
| The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) | Arm 2 - Experimental | Week 9 | 68.6 | Standard Deviation 8.40 | Bpm |
| The Impact on 24-hr Average Heart Rate From Baseline Within Groups | Arm 1 - Active Comparator | -0.6244 | 95% Confidence Interval 7.16 | Bpm | |
| The Impact on 24-hr Average Heart Rate From Baseline Within Groups | Arm 2 - Experimental | -2.9858 | 95% Confidence Interval 6.62 | Bpm | |
| The Different Impact on 24-hr Average Heart Rate Between Two Groups | Arm 1 - Active Comparator | 70.6 | Standard Deviation 7.75 | Bpm | |
| The Different Impact on 24-hr Average Heart Rate Between Two Groups | Arm 2 - Experimental | 69.2 | Standard Deviation 7.82 | Bpm | |
| The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups | Arm 1 - Active Comparator | -0.4938 | 95% Confidence Interval 4.69 | Bpm | |
| The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups | Arm 2 - Experimental | -2.1383 | 95% Confidence Interval 5.71 | Bpm |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Comparator | 125 | |
| Overall Study | STARTED | Experimental | 126 | |
| Overall Study | Patients Included in Safety Population | Active Comparator | 139 | |
| Overall Study | Patients Included in Safety Population | Experimental | 112 | |
| Overall Study | Patients Included in ITT Population | Active Comparator | 116 | |
| Overall Study | Patients Included in ITT Population | Experimental | 115 | |
| Overall Study | Patients Included in PP Population | Active Comparator | 102 | |
| Overall Study | Patients Included in PP Population | Experimental | 89 | |
| Overall Study | COMPLETED | Active Comparator | 113 | |
| Overall Study | COMPLETED | Experimental | 110 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | VIIth nerve paralysis | Nervous system disorders | Active Comparator | 1 | 139 | |
| serious | VIIth nerve paralysis | Nervous system disorders | Experimental | 0 | 112 | |
| serious | Genital neoplasm malignant female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Active Comparator | 0 | 139 | |
| serious | Genital neoplasm malignant female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Experimental | 1 | 112 | |
| serious | Angina pectoris | Cardiac disorders | Active Comparator | 0 | 139 | |
| serious | Angina pectoris | Cardiac disorders | Experimental | 0 | 112 | |
| serious | angina unstable | Cardiac disorders | Active Comparator | 0 | 139 | |
| serious | angina unstable | Cardiac disorders | Experimental | 1 | 112 | |
| serious | Coronary artery occlusion | Cardiac disorders | Active Comparator | 0 | 139 | |
| serious | Coronary artery occlusion | Cardiac disorders | Experimental | 1 | 112 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Comparator | ||
| Total, all-cause mortality | Experimental | ||
| Total, other adverse events | Active Comparator | 0 | 139 |
| Total, other adverse events | Experimental | 0 | 112 |
| Total, serious adverse events | Active Comparator | 1 | 139 |
| Total, serious adverse events | Experimental | 3 | 112 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1 - Active Comparator vs Arm 2 - Experimental: The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups | Trial comparisons |
| Arm 1 - Active Comparator vs Arm 2 - Experimental: The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups | Trial comparisons |
| Active Comparator vs Experimental: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01213173
GET https://conductscience.org/api/trials/v1/NCT01213173/results?page=2