Trial · NCT01251146
A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension
NCT01251146, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension. Trials, record NCT01251146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01251146
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension
- NCT number
- NCT01251146
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 177 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension
- Interventions
- Bisoprolol, Atenolol
- First posted
- 2010-12-01
- Last updated
- 2017-03-08
- Results first posted
- 2012-11-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6) | Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm). |
| Primary | Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up | Baseline and end of follow-up (Week 4 or Week 6 or Week 8) | Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm. |
| Secondary | Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8) | Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm. |
| Secondary | Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up | Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8) | Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm. |
| Secondary | Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment | Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6) | Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm. |
| Secondary | Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6 | Attainment of heart rate goal (Week 2 or Week 4 or Week 6) | Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to end of follow-up (Week 4 or Week 6 or Week 8) | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition |
| Secondary | Number of Participants Compliant With Study Treatment | Baseline up to end of follow-up (Week 4 or Week 6 or Week 8) | Participants compliant with study treatment were the participants who have completed the study treatment regimen. |
Source ClinicalTrials.gov
Outcomes8
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 Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6) | Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively. | millisecond per millimeter of mercury | MEAN |
| PRIMARY | Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up | Baseline and end of follow-up (Week 4 or Week 6 or Week 8) | ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. | millisecond per millimeter of mercury | MEAN |
| SECONDARY | Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8) | ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively. | millisecond square (ms^2) | MEAN |
| SECONDARY | Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up | Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8) | ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively. | ratio | MEAN |
| SECONDARY | Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment | Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6) | ITT population included all randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6 | Attainment of heart rate goal (Week 2 or Week 4 or Week 6) | ITT population included all randomized participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to end of follow-up (Week 4 or Week 6 or Week 8) | Safety population included all randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants Compliant With Study Treatment | Baseline up to end of follow-up (Week 4 or Week 6 or Week 8) | ITT population included all randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
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 Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Bisoprolol | Baseline (n=75,79) | 7.78 | Standard Deviation 2.92 | millisecond per millimeter of mercury |
| Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Atenolol | Baseline (n=75,79) | 7.92 | Standard Deviation 3.26 | millisecond per millimeter of mercury |
| Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Bisoprolol | Change at attainment of heart rate goal (n=67,66) | 3.27 | Standard Deviation 3.67 | millisecond per millimeter of mercury |
| Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal | Atenolol | Change at attainment of heart rate goal (n=67,66) | 2.88 | Standard Deviation 4.05 | millisecond per millimeter of mercury |
| Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up | Bisoprolol | 4.08 | Standard Deviation 3.79 | millisecond per millimeter of mercury | |
| Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up | Atenolol | 3.31 | Standard Deviation 3.83 | millisecond per millimeter of mercury | |
| Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Bisoprolol | HRV for LF at Baseline (n=75,79) | 261.80 | Standard Deviation 208.40 | millisecond square (ms^2) |
| Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Atenolol | HRV for LF at Baseline (n=75,79) | 322.09 | Standard Deviation 315.30 | millisecond square (ms^2) |
| Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Bisoprolol | Change for LF: heart rate goal (n=71,71) | 90.04 | Standard Deviation 352.97 | millisecond square (ms^2) |
| Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up | Atenolol | Change for LF: heart rate goal (n=71,71) | 26.14 | Standard Deviation 416.51 | millisecond square (ms^2) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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 | 86 | |
| Overall Study | STARTED | Atenolol | 91 | |
| Overall Study | COMPLETED | Bisoprolol | 83 | |
| Overall Study | COMPLETED | Atenolol | 81 | |
| Overall Study | NOT COMPLETED | Bisoprolol | 3 | |
| Overall Study | NOT COMPLETED | Atenolol | 10 |
Source ClinicalTrials.gov
Adverse events12
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 | Dizziness | Nervous system disorders | Bisoprolol | 0 | 86 | |
| other | Dizziness | Nervous system disorders | Atenolol | 2 | 91 | |
| other | Headache | Nervous system disorders | Bisoprolol | 0 | 86 | |
| other | Headache | Nervous system disorders | Atenolol | 1 | 91 | |
| other | Elevated Triglyceride | Metabolism and nutrition disorders | Bisoprolol | 4 | 86 | |
| other | Elevated Triglyceride | Metabolism and nutrition disorders | Atenolol | 4 | 91 | |
| other | Elevated Cholesterol | Metabolism and nutrition disorders | Bisoprolol | 2 | 86 | |
| other | Elevated Cholesterol | Metabolism and nutrition disorders | Atenolol | 0 | 91 | |
| other | Bradycardia | Cardiac disorders | Bisoprolol | 0 | 86 | |
| other | Bradycardia | Cardiac disorders | Atenolol | 1 | 91 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | Atenolol | ||
| Total, other adverse events | Bisoprolol | 6 | 86 |
| Total, other adverse events | Atenolol | 6 | 91 |
| Total, serious adverse events | Bisoprolol | 0 | 86 |
| Total, serious adverse events | Atenolol | 0 | 91 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bisoprolol vs Atenolol: Number of Participants Compliant With Study Treatment | Trial comparisons |
| Bisoprolol vs Atenolol: 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/NCT01251146
GET https://conductscience.org/api/trials/v1/NCT01251146/results?page=2