Trial · NCT01190436
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
NCT01190436, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes. Trials, record NCT01190436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190436
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
- NCT number
- NCT01190436
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 125 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension
- Interventions
- Bisoprolol
- First posted
- 2010-08-27
- Last updated
- 2017-01-30
- Results first posted
- 2014-05-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Baseline, Week 12 | The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively. |
| Primary | Percentage of Participants With Controlled BP | Week 12 | Controlled BP was defined as BP less than 130/80 mmHg. |
| Primary | Percentage of Participants With Response to Study Drug | Week 12 | Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline. |
| Primary | Mean Change From Baseline in Heart Rate at Week 12 | Baseline, Week 12 | The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline. |
| Primary | Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 | Week 12 | |
| Secondary | Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 | Week 12 | HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported. |
| Secondary | Mean Change From Baseline in HbA1c at Week 12 | Baseline, Week 12 | HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline. |
| Secondary | Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 | Week 12 | Percentage of participants with increased FBS (greater than 16 milligram per deciliter \[mg/dL\] from baseline) at Week 12 was reported. |
| Secondary | Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 | Baseline, Week 12 | The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline. |
| Secondary | Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 | Baseline, Week 12 | The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively. |
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 |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 | Week 12 | ITT population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in HbA1c at Week 12 | Baseline, Week 12 | ITT population included all participants who received at least 1 dose of study drug. | Percent HbA1c | MEAN |
| PRIMARY | Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug. | mmHg | MEAN |
| PRIMARY | Percentage of Participants With Controlled BP | Week 12 | ITT population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Response to Study Drug | Week 12 | ITT population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Heart Rate at Week 12 | Baseline, Week 12 | ITT population included all participants who received at least 1 dose of study drug. | beats per minute (bpm) | MEAN |
| SECONDARY | Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 | Week 12 | ITT population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 | Baseline, Week 12 | ITT population included all participants who received at least 1 dose of study drug. | mg/dL | MEAN |
| PRIMARY | Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 | Week 12 | ITT population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 | Baseline, Week 12 | ITT population included all participants who received at least 1 dose of study drug. | mg/dL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 | Bisoprolol | 16.8 | 0.6 | percentage of participants | |
| Mean Change From Baseline in HbA1c at Week 12 | Bisoprolol | Baseline | 6.28 | Standard Deviation 0.43 | Percent HbA1c |
| Mean Change From Baseline in HbA1c at Week 12 | Bisoprolol | Change at Week 12 | 0.02 | Standard Deviation 0.59 | Percent HbA1c |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Bisoprolol | Systolic BP: Baseline | 151.7 | Standard Deviation 20.1 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Bisoprolol | Systolic BP: Change at Week 12 | 12.54 | Standard Deviation 18.39 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Bisoprolol | Diastolic BP: Baseline | 87.6 | Standard Deviation 8.2 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 | Bisoprolol | Diastolic BP: Change at Week 12 | 8.48 | Standard Deviation 10.01 | mmHg |
| Percentage of Participants With Controlled BP | Bisoprolol | 42.4 | percentage of participants | ||
| Percentage of Participants With Response to Study Drug | Bisoprolol | 44.0 | percentage of participants | ||
| Mean Change From Baseline in Heart Rate at Week 12 | Bisoprolol | Baseline | 78.2 | Standard Deviation 9.2 | beats per minute (bpm) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bisoprolol | 125 | |
| Overall Study | COMPLETED | Bisoprolol | 86 | |
| Overall Study | NOT COMPLETED | Bisoprolol | 39 |
Source ClinicalTrials.gov
Adverse events13
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 | Hypersensitivity | Immune system disorders | Bisoprolol | 1 | 125 | |
| other | Chest pain | General disorders | Bisoprolol | 1 | 125 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Bisoprolol | 1 | 125 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Bisoprolol | 2 | 125 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Bisoprolol | 1 | 125 | |
| other | Headache | Nervous system disorders | Bisoprolol | 2 | 125 | |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Bisoprolol | 1 | 125 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Bisoprolol | 1 | 125 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Bisoprolol | 1 | 125 | |
| other | Palpitations | Cardiac disorders | Bisoprolol | 1 | 125 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bisoprolol | ||
| Total, other adverse events | Bisoprolol | 8 | 125 |
| Total, serious adverse events | Bisoprolol | 0 | 125 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01190436
GET https://conductscience.org/api/trials/v1/NCT01190436/results?page=2