Trial Outcomes & Findings for A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes (NCT NCT01190436)

NCT ID: NCT01190436

Last Updated: 2017-01-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 125 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2017-01-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	125
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	35
Overall Study Other	4

Baseline Characteristics

A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes

Baseline characteristics by cohort

Measure	Bisoprolol n=125 Participants 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.
Age, Continuous	58.5 years STANDARD_DEVIATION 12.1 • n=5 Participants
Gender Female	73 Participants n=5 Participants
Gender Male	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 Systolic BP: Baseline	151.7 mmHg Standard Deviation 20.1
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 Systolic BP: Change at Week 12	12.54 mmHg Standard Deviation 18.39 • Interval 10.29 to 16.8
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 Diastolic BP: Baseline	87.6 mmHg Standard Deviation 8.2
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 Diastolic BP: Change at Week 12	8.48 mmHg Standard Deviation 10.01 • Interval 6.71 to 10.25

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

Controlled BP was defined as BP less than 130/80 mmHg.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Percentage of Participants With Controlled BP	42.4 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Percentage of Participants With Response to Study Drug	44.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Mean Change From Baseline in Heart Rate at Week 12 Baseline	78.2 beats per minute (bpm) Standard Deviation 9.2
Mean Change From Baseline in Heart Rate at Week 12 Change at Week 12	8.55 beats per minute (bpm) Standard Deviation 9.24

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12	36.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12	16.8 percentage of participants 0.6

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Mean Change From Baseline in HbA1c at Week 12 Baseline	6.28 Percent HbA1c Standard Deviation 0.43
Mean Change From Baseline in HbA1c at Week 12 Change at Week 12	0.02 Percent HbA1c Standard Deviation 0.59

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12	15.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 Baseline	117.1 mg/dL Standard Deviation 25.8
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 Change at Week 12	-5.49 mg/dL Standard Deviation 25.83

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 Total cholesterol: Change at Week 12	1.25 mg/dL Standard Deviation 32.14
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 Total cholesterol: Baseline	183.7 mg/dL Standard Deviation 39.7
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 LDL cholesterol: Baseline	105.5 mg/dL Standard Deviation 31.0
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 LDL cholesterol: Change at Week 12	-1.20 mg/dL Standard Deviation 22.40
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 HDL cholesterol: Baseline	52.0 mg/dL Standard Deviation 15.6
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 HDL cholesterol: Change at Week 12	0.88 mg/dL Standard Deviation 12.23
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 Triglyceride: Baseline	122.8 mg/dL Standard Deviation 55.2
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 Triglyceride: Change at Week 12	2.59 mg/dL Standard Deviation 38.32

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: ITT population included all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Bisoprolol n=125 Participants 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.
Number of Participants With Adverse Events (AEs)	8 participants

Adverse Events

Bisoprolol

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bisoprolol n=125 participants at risk 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.
Immune system disorders Hypersensitivity	0.80% 1/125 • 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.
General disorders Chest pain	0.80% 1/125 • 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.80% 1/125 • 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.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 2/125 • 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.
Gastrointestinal disorders Abdominal pain upper	0.80% 1/125 • 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.
Nervous system disorders Headache	1.6% 2/125 • 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.
Musculoskeletal and connective tissue disorders Neck pain	0.80% 1/125 • 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.80% 1/125 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 1/125 • 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.
Cardiac disorders Palpitations	0.80% 1/125 • 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.
Gastrointestinal disorders Nausea	0.80% 1/125 • 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.
Nervous system disorders Dizziness	0.80% 1/125 • 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.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.80% 1/125 • 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.

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: service@merckgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER