Trial · NCT01508325
Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
NCT01508325, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2015-05-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients. Trials, record NCT01508325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01508325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
- NCT number
- NCT01508325
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 186 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension
- Interventions
- Bisoprolol, Metoprolol
- First posted
- 2012-01-11
- Last updated
- 2015-05-13
- Results first posted
- 2015-05-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (\>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment. |
| Primary | Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment. |
| Secondary | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data \>=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment. |
| Secondary | Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12 | Baseline and Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data \>=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment. |
| Secondary | Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12 | Baseline and Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data \>=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm. |
| Secondary | Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12 | Baseline and Week 12 | The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data \>=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am. |
| Secondary | Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12 | Baseline and Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm. |
| Secondary | Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12 | Baseline and Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am. |
| Secondary | Change From Baseline in 24-hour Blood Pressure Variability at Week 12 | Baseline and Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data \>=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated. |
| Secondary | Blood Pressure Response Rate | Week 12 | Blood pressure response was defined as DBP less than or equal to (=\<) 90 mmHg or \>=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | ITT analysis population included all the randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | beats/min | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | beats/min | MEAN |
| SECONDARY | Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | beats/min | MEAN |
| SECONDARY | Change From Baseline in 24-hour Blood Pressure Variability at Week 12 | Baseline and Week 12 | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | mmHg | MEAN |
| SECONDARY | Blood Pressure Response Rate | Week 12 | ITT analysis population included all randomized subjects. 'N' (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. | percentage of subjects | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Bisoprolol | Baseline (n=92, 93) | 85.28 | Standard Deviation 10.26 | mmHg |
| Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Metoprolol | Baseline (n=92, 93) | 85.68 | Standard Deviation 11.59 | mmHg |
| Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Bisoprolol | Change at Week 12 (n=65, 66) | -4.45 | Standard Deviation 10.74 | mmHg |
| Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Metoprolol | Change at Week 12 (n=65, 66) | -3.39 | Standard Deviation 11.23 | mmHg |
| Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Bisoprolol | Baseline (n=92, 93) | 75.67 | Standard Deviation 10.58 | beats/min |
| Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Metoprolol | Baseline (n=92, 93) | 73.99 | Standard Deviation 9.90 | beats/min |
| Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Bisoprolol | Change at Week 12 (n=65, 66) | -8.04 | Standard Deviation 12.65 | beats/min |
| Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Metoprolol | Change at Week 12 (n=65, 66) | -4.75 | Standard Deviation 11.34 | beats/min |
| Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | Bisoprolol | Baseline (n=92, 93) | 132.68 | Standard Deviation 15.96 | mmHg |
| Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | Metoprolol | Baseline (n=92, 93) | 133.24 | Standard Deviation 16.69 | mmHg |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bisoprolol | 93 | |
| Overall Study | STARTED | Metoprolol | 93 | |
| Overall Study | COMPLETED | Bisoprolol | 75 | |
| Overall Study | COMPLETED | Metoprolol | 72 | |
| Overall Study | NOT COMPLETED | Bisoprolol | 18 | |
| Overall Study | NOT COMPLETED | Metoprolol | 21 |
Source ClinicalTrials.gov
Adverse events60
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 |
|---|---|---|---|---|---|---|
| other | Angina | Cardiac disorders | Bisoprolol | 1 | 93 | |
| other | Angina | Cardiac disorders | Metoprolol | 0 | 93 | |
| other | Bradycardia | Cardiac disorders | Bisoprolol | 1 | 93 | |
| other | Bradycardia | Cardiac disorders | Metoprolol | 0 | 93 | |
| other | Coronary artery disease | Cardiac disorders | Bisoprolol | 1 | 93 | |
| other | Coronary artery disease | Cardiac disorders | Metoprolol | 0 | 93 | |
| other | Myocardial ischemia | Cardiac disorders | Bisoprolol | 0 | 93 | |
| other | Myocardial ischemia | Cardiac disorders | Metoprolol | 1 | 93 | |
| other | Palpitation | Cardiac disorders | Bisoprolol | 1 | 93 | |
| other | Palpitation | Cardiac disorders | Metoprolol | 2 | 93 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bisoprolol | ||
| Total, all-cause mortality | Metoprolol | ||
| Total, other adverse events | Bisoprolol | 17 | 93 |
| Total, other adverse events | Metoprolol | 16 | 93 |
| Total, serious adverse events | Bisoprolol | 2 | 93 |
| Total, serious adverse events | Metoprolol | 0 | 93 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bisoprolol vs Metoprolol: serious adverse events |
Source 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/NCT01508325
GET https://conductscience.org/api/trials/v1/NCT01508325/results?page=2