Trial Outcomes & Findings for Open-Labeled PK-PD Studies of Metoprolol ER (NCT NCT02417246)
NCT ID: NCT02417246
Last Updated: 2020-02-10
Results Overview
The AUC of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and standard deviation (SD) values of AUC are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dose
Results posted on
2020-02-10
Participant Flow
61 participants were consented with 10 participants as screen fails, 2 declining to further participate, and 1 unable to fit standard monitoring equipment.
Participant milestones
| Measure |
Sequence A
Brand name metoprolol ER for 7 to 28 days, and then switch to generic B metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic A metoprolol for 7 days
|
Sequence B
Brand name metoprolol ER for 7 to 28 days, and then switch to generic A metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic B metoprolol for 7 days
|
|---|---|---|
|
Phase 1 Brand Name Metoprolol ER
STARTED
|
24
|
24
|
|
Phase 1 Brand Name Metoprolol ER
COMPLETED
|
20
|
20
|
|
Phase 1 Brand Name Metoprolol ER
NOT COMPLETED
|
4
|
4
|
|
Phase 2 1st Generic Administered
STARTED
|
20
|
20
|
|
Phase 2 1st Generic Administered
COMPLETED
|
19
|
20
|
|
Phase 2 1st Generic Administered
NOT COMPLETED
|
1
|
0
|
|
Phase 3 Brand Name Metoprolol ER #2
STARTED
|
19
|
20
|
|
Phase 3 Brand Name Metoprolol ER #2
COMPLETED
|
18
|
20
|
|
Phase 3 Brand Name Metoprolol ER #2
NOT COMPLETED
|
1
|
0
|
|
Phase 4 2nd Generic Administered
STARTED
|
18
|
20
|
|
Phase 4 2nd Generic Administered
COMPLETED
|
18
|
20
|
|
Phase 4 2nd Generic Administered
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence A
Brand name metoprolol ER for 7 to 28 days, and then switch to generic B metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic A metoprolol for 7 days
|
Sequence B
Brand name metoprolol ER for 7 to 28 days, and then switch to generic A metoprolol for 7 days, Brand name metoprolol ER for 7 to 28 days, generic B metoprolol for 7 days
|
|---|---|---|
|
Phase 1 Brand Name Metoprolol ER
Lost to Follow-up
|
1
|
1
|
|
Phase 1 Brand Name Metoprolol ER
Physician Decision
|
1
|
0
|
|
Phase 1 Brand Name Metoprolol ER
Withdrawal by Subject
|
2
|
3
|
|
Phase 2 1st Generic Administered
Physician Decision
|
1
|
0
|
Baseline Characteristics
18 subjects who were administered both brand name metoprolol ER and Generic A; and 18 subjects who were administered both brand name metoprolol ER and Generic B were analyzed
Baseline characteristics by cohort
| Measure |
Sequence A: Brand Name Metoprolol ER and Generic B
n=18 Participants
This group will start with the brand name metoprolol ER for 7 to 28 days, and then switch to Generic B metoprolol for 7 days.
Brand name metoprolol ER: This medication will be taken for 7 to 28 days
Generic B metoprolol: This medication will be taken for 7 days
Generic A metoprolol: This medication will be taken for 7 days
|
Sequence B: Brand Name Metoprolol ER and Generic A
n=18 Participants
This group will start with the brand name metoprolol ER for 7 to 28 days, and then switch to Generic A metoprolol for 7 days.
Brand name metoprolol ER: This medication will be taken for 7 to 28 days
Generic A metoprolol: This medication will be taken for 7 days
Generic B metoprolol: This medication will be taken for 7 days
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 11 • n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic A; and 18 subjects who were administered both brand name metoprolol ER and Generic B were analyzed
|
51 years
STANDARD_DEVIATION 12 • n=7 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic A; and 18 subjects who were administered both brand name metoprolol ER and Generic B were analyzed
|
53 years
STANDARD_DEVIATION 12 • n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic A; and 18 subjects who were administered both brand name metoprolol ER and Generic B were analyzed
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
8 Participants
n=7 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
17 Participants
n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
10 Participants
n=7 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
19 Participants
n=5 Participants • 18 subjects who were administered both brand name metoprolol ER and Generic B and 18 subjects who were administered both brand name metoprolol ER and Generic A were analyzed
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
BMI
|
30 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 5 • n=7 Participants
|
30 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Weight
|
85 kg
STANDARD_DEVIATION 15 • n=5 Participants
|
93 kg
STANDARD_DEVIATION 23 • n=7 Participants
|
89 kg
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Height
|
169 cm
STANDARD_DEVIATION 10 • n=5 Participants
|
172 cm
STANDARD_DEVIATION 12 • n=7 Participants
|
171 cm
STANDARD_DEVIATION 11 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dosePopulation: This is a 2-way crossover analysis
The AUC of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and standard deviation (SD) values of AUC are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.
Outcome measures
| Measure |
Brand Name Metoprolol ER
n=36 Plasma
Brand name metoprolol ER received in Phase 1
|
Generic B
n=35 Plasma
Generic B received in Phase 2 or Phase 4
|
Generic A
n=35 Plasma
Generic A received in Phase 2 or Phase 4
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
50mg
|
645.5 ng.hr/ml
Standard Deviation 461.4
|
633.0 ng.hr/ml
Standard Deviation 523.2
|
654.0 ng.hr/ml
Standard Deviation 446.0
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
100mg
|
1584.4 ng.hr/ml
Standard Deviation 671.1
|
1446.8 ng.hr/ml
Standard Deviation 604.3
|
1492.3 ng.hr/ml
Standard Deviation 393.3
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
150mg
|
12176.1 ng.hr/ml
Standard Deviation 7686.6
|
12790.2 ng.hr/ml
Standard Deviation 0
|
9926.6 ng.hr/ml
Standard Deviation 4383.9
|
PRIMARY outcome
Timeframe: 0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dosePopulation: A two-way cross over study in which patients are administered brand name metoprolol ER and Generic B or Generic A
The Peak Plasma Concentration (Cmax) of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and SD values of Cmax are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.
Outcome measures
| Measure |
Brand Name Metoprolol ER
n=36 Participants
Brand name metoprolol ER received in Phase 1
|
Generic B
n=35 Participants
Generic B received in Phase 2 or Phase 4
|
Generic A
n=35 Participants
Generic A received in Phase 2 or Phase 4
|
|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Metoprolol Succinate
50mg
|
36.6 ng/mL
Standard Deviation 24.0
|
35.0 ng/mL
Standard Deviation 26.9
|
39.9 ng/mL
Standard Deviation 22.9
|
|
Peak Plasma Concentration (Cmax) of Metoprolol Succinate
100mg
|
87.8 ng/mL
Standard Deviation 33.3
|
76.5 ng/mL
Standard Deviation 31.3
|
83.0 ng/mL
Standard Deviation 20.9
|
|
Peak Plasma Concentration (Cmax) of Metoprolol Succinate
150mg
|
653.3 ng/mL
Standard Deviation 399.8
|
613.8 ng/mL
Standard Deviation 87.1
|
477.0 ng/mL
Standard Deviation 193.7
|
SECONDARY outcome
Timeframe: Heart rate variability (Low-to-High Frequency Ratio) over each quartile of 6 hours in the 24-hr periodPopulation: The analysis aimed to compare HRV (Low-to-High Frequency Ratio) for patients who took Brand name metoprolol ER and a generic formulation (Generic B or Generic A). Low to High Frequency Ratio values are entered for each quartile for Brand name metoprolol ER, Generic B and Generic A
24-h digital heart rate monitor analyses were obtained after Phase 1 (brand name metoprolol ER ), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B). Data were analyzed by quartiles. One 5-minute epoch from each hour of each quartile was selected based on absence of a significant number of ectopic beats and artifact from which spectral measures were calculated: high-frequency variability (measure of parasympathetic activity), low-frequency variability (measure of sympathetic activity). The ratio of low-to-high frequency variability was calculated for each quartile. The averages of values obtained for each hour of each quartile constituted the final quartile measures that were used for analysis. The low to high frequency ratio obtained for each quartile represents the balance between sympathetic and parasympathetic nervous system activity and was the primary variable for heart rate variability analysis.
Outcome measures
| Measure |
Brand Name Metoprolol ER
n=36 Participants
Brand name metoprolol ER received in Phase 1
|
Generic B
n=35 Participants
Generic B received in Phase 2 or Phase 4
|
Generic A
n=35 Participants
Generic A received in Phase 2 or Phase 4
|
|---|---|---|---|
|
The Heart Rate Variability (HRV) Response to Brand Name Metoprolol ER Versus Each Generic Formulation of Metoprolol Succinate.
Low to High Frequency Ratio: Quartile1
|
2.08 no units
Standard Deviation 2.43
|
1.67 no units
Standard Deviation 1.21
|
1.79 no units
Standard Deviation 1.06
|
|
The Heart Rate Variability (HRV) Response to Brand Name Metoprolol ER Versus Each Generic Formulation of Metoprolol Succinate.
Low to High Frequency Ratio: Quartile 2
|
2.06 no units
Standard Deviation 1.74
|
1.64 no units
Standard Deviation 1.05
|
1.95 no units
Standard Deviation 1.50
|
|
The Heart Rate Variability (HRV) Response to Brand Name Metoprolol ER Versus Each Generic Formulation of Metoprolol Succinate.
Low to High Frequency Ratio: Quartile 3
|
2.06 no units
Standard Deviation 1.57
|
1.92 no units
Standard Deviation 1.21
|
2.08 no units
Standard Deviation 0.99
|
|
The Heart Rate Variability (HRV) Response to Brand Name Metoprolol ER Versus Each Generic Formulation of Metoprolol Succinate.
Low to High Frequency Ratio: Quartile 4
|
1.95 no units
Standard Deviation 1.18
|
2.22 no units
Standard Deviation 1.79
|
2.34 no units
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Average value over each quartile of 6 hours in the 24-hr periodPopulation: The analysis aimed to compare mean BP values in Hg mm between the brand name and each of the generic (Generic B or Generic A) formulation of metoprolol succinate. Patients were included in the analysis if they took brand name metoprolol ER and at least one generic.
24-hr ambulatory blood pressure (BP) recordings taken 4 times per hour (every 15 minutes) between 6AM and 11PM and 2 times per hour (every 30 minutes) 11PM and 6AM were obtained after Phase 1 (Brand name metoprolol ER), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B).
Outcome measures
| Measure |
Brand Name Metoprolol ER
n=36 Participants
Brand name metoprolol ER received in Phase 1
|
Generic B
n=35 Participants
Generic B received in Phase 2 or Phase 4
|
Generic A
n=35 Participants
Generic A received in Phase 2 or Phase 4
|
|---|---|---|---|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Systolic Blood Pressure: quartile 1
|
132.8 mm Hg
Standard Deviation 14.1
|
129.6 mm Hg
Standard Deviation 15.0
|
129.1 mm Hg
Standard Deviation 15.1
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Systolic Blood Pressure: quartile 2
|
134.1 mm Hg
Standard Deviation 16.0
|
131.3 mm Hg
Standard Deviation 16.1
|
131.0 mm Hg
Standard Deviation 16.4
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Systolic Blood Pressure: quartile 3
|
124.1 mm Hg
Standard Deviation 17.2
|
121.0 mm Hg
Standard Deviation 16.3
|
123.1 mm Hg
Standard Deviation 15.6
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Systolic Blood Pressure: quartile 4
|
129.3 mm Hg
Standard Deviation 16.6
|
127.7 mm Hg
Standard Deviation 17.0
|
128.0 mm Hg
Standard Deviation 15.8
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Diastolic Blood Pressure: quartile 1
|
80.8 mm Hg
Standard Deviation 10.5
|
79.3 mm Hg
Standard Deviation 10.2
|
78.3 mm Hg
Standard Deviation 11.1
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Diastolic Blood Pressure: quartile 2
|
80.8 mm Hg
Standard Deviation 11.6
|
80.3 mm Hg
Standard Deviation 11.4
|
78.5 mm Hg
Standard Deviation 11.7
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Diastolic Blood Pressure: quartile 3
|
75.4 mm Hg
Standard Deviation 13.2
|
73.2 mm Hg
Standard Deviation 11.4
|
74.4 mm Hg
Standard Deviation 10.4
|
|
Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)
Diastolic Blood Pressure: quartile 4
|
79.2 mm Hg
Standard Deviation 10.4
|
80.0 mm Hg
Standard Deviation 13.3
|
78.1 mm Hg
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Average value over each quartile of 6 hours in the 24-hr periodPopulation: The analysis aimed to compare 24-hr HR between the brand name and each generic (generic B or generic A) formulation of metoprolol succinate. Mean and SD values for HR entered for each medication by quartile
24-h ambulatory heart rate recordings taken 4 times per hour (every 15 minutes) between 6AM and 11PM and 2 times per hour (every 30 minutes) 11PM and 6AM were obtained after Phase 1 (brand name metoprolol ER), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B)
Outcome measures
| Measure |
Brand Name Metoprolol ER
n=36 Participants
Brand name metoprolol ER received in Phase 1
|
Generic B
n=35 Participants
Generic B received in Phase 2 or Phase 4
|
Generic A
n=35 Participants
Generic A received in Phase 2 or Phase 4
|
|---|---|---|---|
|
Heart Rate (HR) Response Compared Between Brand Name Metoprolol ER and Each Generic (Generic B, Generic A) Formulation of Metoprolol Succinate
HR (beats per minute) Quartile one
|
65.1 bpm
Standard Deviation 11.5
|
65.4 bpm
Standard Deviation 11.5
|
66.1 bpm
Standard Deviation 11.3
|
|
Heart Rate (HR) Response Compared Between Brand Name Metoprolol ER and Each Generic (Generic B, Generic A) Formulation of Metoprolol Succinate
HR (beats per minute) Quartile two
|
65.3 bpm
Standard Deviation 11.5
|
65.9 bpm
Standard Deviation 10.5
|
66.9 bpm
Standard Deviation 11.5
|
|
Heart Rate (HR) Response Compared Between Brand Name Metoprolol ER and Each Generic (Generic B, Generic A) Formulation of Metoprolol Succinate
HR (beats per minute) Quartile three
|
61.3 bpm
Standard Deviation 9.9
|
62.8 bpm
Standard Deviation 10.1
|
63.4 bpm
Standard Deviation 10.6
|
|
Heart Rate (HR) Response Compared Between Brand Name Metoprolol ER and Each Generic (Generic B, Generic A) Formulation of Metoprolol Succinate
HR (beats per minute) Quartile four
|
61.4 bpm
Standard Deviation 12.9
|
62.5 bpm
Standard Deviation 11.6
|
62.5 bpm
Standard Deviation 11.3
|
Adverse Events
Brand Name
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Generic A
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Generic B
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brand Name
n=48 participants at risk
Brand Name Metoprolol ER
|
Generic A
n=38 participants at risk
Generic Metoprolol ER type A
|
Generic B
n=40 participants at risk
Generic Metoprolol ER type B
|
|---|---|---|---|
|
Investigations
ECG signs of myocardia ischemia
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
Other adverse events
| Measure |
Brand Name
n=48 participants at risk
Brand Name Metoprolol ER
|
Generic A
n=38 participants at risk
Generic Metoprolol ER type A
|
Generic B
n=40 participants at risk
Generic Metoprolol ER type B
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infections
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
General disorders
Dyspepsia
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Cardiac disorders
Bradycardia
|
4.2%
2/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Nervous system disorders
Dizziness
|
4.2%
2/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
5.0%
2/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
General disorders
Fatigue
|
16.7%
8/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
5.3%
2/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Vascular disorders
Hypertension
|
4.2%
2/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
5.0%
2/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Nervous system disorders
Headache
|
12.5%
6/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
7.9%
3/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
10.0%
4/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
General disorders
Sluggishness
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
General disorders
Hyperhidrosis
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Vascular disorders
Syncope
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Infections and infestations
Bronchitis
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Cardiac disorders
Palpitations
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Vascular disorders
Flushing
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Cardiac disorders
Dyspnoea
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
5.3%
2/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
General disorders
Influenza like illness
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
5.3%
2/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
2/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Injury, poisoning and procedural complications
Puncture site reaction
|
8.3%
4/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Psychiatric disorders
Depression
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Nervous system disorders
Pre syncope
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.5%
1/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Nervous system disorders
Skin burning sensation
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.1%
1/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/48 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
2.6%
1/38 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
0.00%
0/40 • Up to 12 weeks since the start of phase one (patients starting their first dose of brand name metoprolol ER)
Safety population included all patients who took at least one dose of study drug (i.e. one dose of brand name metoprolol ER in Phase 1)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place