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| Name | Class |
|---|---|
| Merck Inc., Philippines | INDUSTRY |
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The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisoprolol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 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. | Baseline, Week 12 |
| Percentage of Participants With Controlled BP | Controlled BP was defined as BP less than 130/80 mmHg. | Week 12 |
| Percentage of Participants With Response to Study Drug | Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline. | Week 12 |
| Mean Change From Baseline in Heart Rate at Week 12 | The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline. | Baseline, Week 12 |
| Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at 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. | Week 12 |
| Mean Change From Baseline in HbA1c at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Inc., Philippines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Manila | Philippines |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bisoprolol | Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bisoprolol | Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at 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. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 12 |
|
Baseline up to Week 12
Serious Adverse event (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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bisoprolol | Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| C086062 | bisoprolol, hydrochlorothiazide drug combination |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
|
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. |
| Baseline, Week 12 |
| Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 | Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported. | Week 12 |
| Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 | The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline. | Baseline, Week 12 |
| Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at 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. | Baseline, Week 12 |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. | Baseline up to Week 12 |
| years |
|
| Gender | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Mean Change From Baseline in HbA1c at 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. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percent HbA1c | Baseline, Week 12 |
|
|
|
| Primary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 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. | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
|
|
|
| Primary | Percentage of Participants With Controlled BP | Controlled BP was defined as BP less than 130/80 mmHg. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Primary | Percentage of Participants With Response to Study Drug | Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Primary | Mean Change From Baseline in Heart Rate at Week 12 | The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 | Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Secondary | Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 | The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12 |
|
|
|
| Primary | Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Secondary | Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at 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. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Week 12 |
|
|
|
| 0 |
| 125 |
| 8 |
| 125 |
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
PI shall make no press release, advertising or other promotional written or oral statements to public in connection with any reference to Sponsor's name of any member of Sponsor's staff, or PI, without prior approval of Sponsor or designated agent.
PI and/or Co-I shall not publish any information related to study data/results without first obtaining prior written consent of Sponsor and agrees to submit to Sponsor for review, a copy of any proposed publication resulting from completed study.
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
|
| Diastolic BP: Change at Week 12 |
|
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| LDL cholesterol: Change at Week 12 |
|
| HDL cholesterol: Baseline |
|
| HDL cholesterol: Change at Week 12 |
|
| Triglyceride: Baseline |
|
| Triglyceride: Change at Week 12 |
|