Trial · NCT01079962
An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
NCT01079962, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION]). Trials, record NCT01079962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01079962
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
- NCT number
- NCT01079962
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 209 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension
- Interventions
- Bisoprolol, Atenolol
- First posted
- 2010-03-03
- Last updated
- 2014-02-13
- Results first posted
- 2012-10-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Baseline and Week 12 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline. |
| Primary | Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12 | Baseline and Week 12 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline. |
| Secondary | Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in aortic BP (aortic systolic blood pressure \[SBP\], aortic diastolic blood pressure \[DBP\] and aortic mean blood pressure \[BP\]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline. |
| Secondary | Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline. |
| Secondary | Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline. |
| Secondary | Change From Baseline in Heart Rate at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline. |
| Secondary | Change From Baseline in Aortic Pulse Pressure (APP) at Week 4 | Baseline and Week 4 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline. |
| Secondary | Change From Baseline in Lipid Levels at Week 12 | Baseline and Week 12 | The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline. |
| Secondary | Change From Baseline in Blood Glucose Levels at Week 12 | Baseline and Week 12 | The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline. |
| Secondary | Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Baseline and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | Millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | Ratio | MEAN |
| SECONDARY | Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | Meters per second (m/s) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | Beats per minute (bpm) | MEAN |
| SECONDARY | Change From Baseline in Aortic Pulse Pressure (APP) at Week 4 | Baseline and Week 4 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Lipid Levels at Week 12 | Baseline and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. | Milligram/decilitre (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Blood Glucose Levels at Week 12 | Baseline and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point. | mmHg | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Baseline up to Week 14 (follow-up visit) | ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group56
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 Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Bisoprolol | Baseline (n=96, 95) | 47.49 | Standard Deviation 11.33 | Millimeter of mercury (mmHg) |
| Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Atenolol | Baseline (n=96, 95) | 45.93 | Standard Deviation 11.62 | Millimeter of mercury (mmHg) |
| Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Bisoprolol | Change in APP at Week 12 (n=90, 89) | -4.40 | Standard Deviation 9.29 | Millimeter of mercury (mmHg) |
| Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Atenolol | Change in APP at Week 12 (n=90, 89) | -3.69 | Standard Deviation 8.86 | Millimeter of mercury (mmHg) |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Bisoprolol | Change in aortic SBP at Week 4 (n=96, 95) | -13.90 | Standard Deviation 12.68 | mmHg |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Atenolol | Change in aortic SBP at Week 4 (n=96, 95) | -13.57 | Standard Deviation 12.73 | mmHg |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Bisoprolol | Change in aortic SBP at Week 12 (n=90, 89) | -15.34 | Standard Deviation 15.11 | mmHg |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Atenolol | Change in aortic SBP at Week 12 (n=90, 89) | -12.71 | Standard Deviation 14.67 | mmHg |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Bisoprolol | Change in aortic DBP at Week 4 (n=96, 95) | -10.86 | Standard Deviation 8.23 | mmHg |
| Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Atenolol | Change in aortic DBP at Week 4 (n=96, 95) | -9.47 | Standard Deviation 8.23 | mmHg |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 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 | 105 | |
| Overall Study | STARTED | Atenolol | 104 | |
| Overall Study | COMPLETED | Bisoprolol | 90 | |
| Overall Study | COMPLETED | Atenolol | 89 | |
| Overall Study | NOT COMPLETED | Bisoprolol | 15 | |
| Overall Study | NOT COMPLETED | Atenolol | 15 |
Source ClinicalTrials.gov
Adverse events136
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 | Gallbladder disorder | Hepatobiliary disorders | Bisoprolol | 0 | 105 | |
| other | Gallbladder disorder | Hepatobiliary disorders | Atenolol | 1 | 104 | |
| other | Liver fatty | Hepatobiliary disorders | Bisoprolol | 0 | 105 | |
| other | Liver fatty | Hepatobiliary disorders | Atenolol | 2 | 104 | |
| other | Cramps | Musculoskeletal and connective tissue disorders | Bisoprolol | 1 | 105 | |
| other | Cramps | Musculoskeletal and connective tissue disorders | Atenolol | 0 | 104 | |
| other | Arthralgia aggravated | Musculoskeletal and connective tissue disorders | Bisoprolol | 1 | 105 | |
| other | Arthralgia aggravated | Musculoskeletal and connective tissue disorders | Atenolol | 0 | 104 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Bisoprolol | 1 | 105 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Atenolol | 1 | 104 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 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 | 29 | 105 |
| Total, other adverse events | Atenolol | 29 | 104 |
| Total, serious adverse events | Bisoprolol | 7 | 105 |
| Total, serious adverse events | Atenolol | 3 | 104 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23385648 | DERIVED |
Source PubMed
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 With Adverse Events (AEs) | 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/NCT01079962
GET https://conductscience.org/api/trials/v1/NCT01079962/results?page=2