Trial · NCT01977794
Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension
NCT01977794, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension. Trials, record NCT01977794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01977794
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension
- NCT number
- NCT01977794
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension
- Interventions
- Bisoprolol/Amlodipine (Bisoprolol failed group), Bisoprolol/Amlodipine (Amlodipine failed group)
- First posted
- 2013-11-07
- Last updated
- 2017-01-30
- Results first posted
- 2016-08-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Baseline, Week 18 | Baseline was defined as the latest SBP under monotherapy. |
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Baseline, Week 18 | Baseline was defined as the latest DBP before study treatment administration. |
| Secondary | Percentage of Subjects With Controlled Blood Pressure | Baseline up to Week 18 | |
| Secondary | Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment | Baseline, Week 18 | Baseline was defined as the latest HR before study treatment administration |
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death | Baseline up to Day 127 (end of trial) | An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Baseline, Week 18 | MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Baseline, Week 18 | MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. | mmHg | MEAN |
| SECONDARY | Percentage of Subjects With Controlled Blood Pressure | Baseline up to Week 18 | MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment | Baseline, Week 18 | MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. | beats per minute | MEAN |
| SECONDARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death | Baseline up to Day 127 (end of trial) | Safety analysis set included all subjects who received at least 1 dose of IMP. | subjects | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Amlodipine Failed Group | Baseline | 150.6 | Standard Deviation 8.21 | millimeters of mercury (mmHg) |
| Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Bisoprolol Failed Group | Baseline | 151.6 | Standard Deviation 11.57 | millimeters of mercury (mmHg) |
| Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Amlodipine Failed Group | Change at Week 18 | -24.7 | Standard Deviation 11.67 | millimeters of mercury (mmHg) |
| Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline | Bisoprolol Failed Group | Change at Week 18 | -25.9 | Standard Deviation 12.82 | millimeters of mercury (mmHg) |
| Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Amlodipine Failed Group | Baseline | 90.5 | Standard Deviation 6.92 | mmHg |
| Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Bisoprolol Failed Group | Baseline | 92.0 | Standard Deviation 8.81 | mmHg |
| Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Amlodipine Failed Group | Change at Week 18 | -13.0 | Standard Deviation 9.38 | mmHg |
| Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment | Bisoprolol Failed Group | Change at Week 18 | -14.0 | Standard Deviation 7.73 | mmHg |
| Percentage of Subjects With Controlled Blood Pressure | Amlodipine Failed Group | Week 6 | 85.6 | percentage of subjects | |
| Percentage of Subjects With Controlled Blood Pressure | Bisoprolol Failed Group | Week 6 | 80.8 | percentage of subjects |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine Failed Group | 100 | |
| Overall Study | STARTED | Bisoprolol Failed Group | 100 | |
| Overall Study | COMPLETED | Amlodipine Failed Group | 92 | |
| Overall Study | COMPLETED | Bisoprolol Failed Group | 94 | |
| Overall Study | NOT COMPLETED | Amlodipine Failed Group | 8 | |
| Overall Study | NOT COMPLETED | Bisoprolol Failed Group | 6 |
Source ClinicalTrials.gov
Adverse events20
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 | Sinus bradycardia | Cardiac disorders | Amlodipine Failed Group | 30 | 100 | |
| other | Sinus bradycardia | Cardiac disorders | Bisoprolol Failed Group | 25 | 100 | |
| other | Bradycardia | Cardiac disorders | Amlodipine Failed Group | 20 | 100 | |
| other | Bradycardia | Cardiac disorders | Bisoprolol Failed Group | 15 | 100 | |
| other | Oedema peripheral | General disorders | Amlodipine Failed Group | 9 | 100 | |
| other | Oedema peripheral | General disorders | Bisoprolol Failed Group | 9 | 100 | |
| other | Urinary tract infection | Infections and infestations | Amlodipine Failed Group | 6 | 100 | |
| other | Urinary tract infection | Infections and infestations | Bisoprolol Failed Group | 9 | 100 | |
| other | Upper respiratory tract infection | Infections and infestations | Amlodipine Failed Group | 4 | 100 | |
| other | Upper respiratory tract infection | Infections and infestations | Bisoprolol Failed Group | 5 | 100 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine Failed Group | ||
| Total, all-cause mortality | Bisoprolol Failed Group | ||
| Total, other adverse events | Amlodipine Failed Group | 63 | 100 |
| Total, other adverse events | Bisoprolol Failed Group | 53 | 100 |
| Total, serious adverse events | Amlodipine Failed Group | 1 | 100 |
| Total, serious adverse events | Bisoprolol Failed Group | 2 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27334671 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amlodipine Failed Group vs Bisoprolol Failed Group: 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/NCT01977794
GET https://conductscience.org/api/trials/v1/NCT01977794/results?page=2