Trial Outcomes & Findings for Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension (NCT NCT01977794)
NCT ID: NCT01977794
Last Updated: 2017-01-30
Results Overview
Baseline was defined as the latest SBP under monotherapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Baseline, Week 18
Results posted on
2017-01-30
Participant Flow
The study was conducted at 10 clinical trial sites in Guatemala.
A total of 200 subjects (100 subjects in the amlodipine failed group, and 100 subjects in the bisoprolol failed group) were enrolled and randomized in the trial. Out of which 196 subjects (97 subjects in amlodipine failed group and 99 subjects in bisoprolol failed group) were included in modified intent-to-treat (MITT) analysis set.
Participant milestones
| Measure |
Amlodipine Failed Group
Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)\<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)\<90mmHg.
|
Bisoprolol Failed Group
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
92
|
94
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Amlodipine Failed Group
Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)\<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)\<90mmHg.
|
Bisoprolol Failed Group
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrew consent
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension
Baseline characteristics by cohort
| Measure |
Amlodipine Failed Group
n=97 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=99 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Gender
Female
|
77 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 18Population: 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.
Baseline was defined as the latest SBP under monotherapy.
Outcome measures
| Measure |
Amlodipine Failed Group
n=92 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=94 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
Baseline
|
150.6 millimeters of mercury (mmHg)
Standard Deviation 8.21
|
151.6 millimeters of mercury (mmHg)
Standard Deviation 11.57
|
|
Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
Change at Week 18
|
-24.7 millimeters of mercury (mmHg)
Standard Deviation 11.67
|
-25.9 millimeters of mercury (mmHg)
Standard Deviation 12.82
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: 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.
Baseline was defined as the latest DBP before study treatment administration.
Outcome measures
| Measure |
Amlodipine Failed Group
n=92 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=94 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment
Baseline
|
90.5 mmHg
Standard Deviation 6.92
|
92.0 mmHg
Standard Deviation 8.81
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment
Change at Week 18
|
-13.0 mmHg
Standard Deviation 9.38
|
-14.0 mmHg
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Baseline up to Week 18Population: MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP.
Outcome measures
| Measure |
Amlodipine Failed Group
n=97 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=99 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Percentage of Subjects With Controlled Blood Pressure
Week 6
|
85.6 percentage of subjects
|
80.8 percentage of subjects
|
|
Percentage of Subjects With Controlled Blood Pressure
Week 12
|
86.8 percentage of subjects
|
87.9 percentage of subjects
|
|
Percentage of Subjects With Controlled Blood Pressure
Week 18
|
86.7 percentage of subjects
|
89.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: 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.
Baseline was defined as the latest HR before study treatment administration
Outcome measures
| Measure |
Amlodipine Failed Group
n=89 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=94 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment
Baseline
|
73.6 beats per minute
Standard Deviation 8.96
|
69.9 beats per minute
Standard Deviation 9.70
|
|
Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment
Change from baseline at Week 18
|
-11.5 beats per minute
Standard Deviation 8.65
|
-6.6 beats per minute
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: Baseline up to Day 127 (end of trial)Population: Safety analysis set included all subjects who received at least 1 dose of IMP.
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.
Outcome measures
| Measure |
Amlodipine Failed Group
n=100 Participants
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=100 Participants
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
TEAEs
|
78 subjects
|
71 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
Serious TEAEs
|
1 subjects
|
2 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
AEs leading to discontinuation
|
3 subjects
|
3 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
AEs leading to death
|
1 subjects
|
1 subjects
|
Adverse Events
Amlodipine Failed Group
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Bisoprolol Failed Group
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amlodipine Failed Group
n=100 participants at risk
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=100 participants at risk
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/100 • Baseline up to Day 127
|
0.00%
0/100 • Baseline up to Day 127
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/100 • Baseline up to Day 127
|
1.0%
1/100 • Baseline up to Day 127
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/100 • Baseline up to Day 127
|
1.0%
1/100 • Baseline up to Day 127
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/100 • Baseline up to Day 127
|
1.0%
1/100 • Baseline up to Day 127
|
Other adverse events
| Measure |
Amlodipine Failed Group
n=100 participants at risk
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
Bisoprolol Failed Group
n=100 participants at risk
Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP \<140 mmHg and DBP \<90 mmHg.
|
|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
30.0%
30/100 • Baseline up to Day 127
|
25.0%
25/100 • Baseline up to Day 127
|
|
Cardiac disorders
Bradycardia
|
20.0%
20/100 • Baseline up to Day 127
|
15.0%
15/100 • Baseline up to Day 127
|
|
General disorders
Oedema peripheral
|
9.0%
9/100 • Baseline up to Day 127
|
9.0%
9/100 • Baseline up to Day 127
|
|
Infections and infestations
Urinary tract infection
|
6.0%
6/100 • Baseline up to Day 127
|
9.0%
9/100 • Baseline up to Day 127
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
4/100 • Baseline up to Day 127
|
5.0%
5/100 • Baseline up to Day 127
|
|
Injury, poisoning and procedural complications
Overdose
|
8.0%
8/100 • Baseline up to Day 127
|
7.0%
7/100 • Baseline up to Day 127
|
Additional Information
Merck KGaA Communication Center
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Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place