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| Name | Class |
|---|---|
| Merck Serono Co., Ltd., China | INDUSTRY |
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This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.
Primary objectives:
To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week active treatment in subjects with mild to moderate essential hypertension (EH).
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisoprolol | Experimental |
| |
| Metoprolol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment. | Baseline and Week 12 |
| Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Serono Co., Ltd., China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Serono Investigational Site | Changsha | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bisoprolol | Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks. |
| FG001 | Metoprolol | Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat (ITT) analysis population included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bisoprolol | Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment | Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment. | ITT analysis population included all the randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
From the first administration of the trial medication up to the end of the treatment (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bisoprolol | Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
|
| Metoprolol | Drug | Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
|
|
| Baseline and Week 12 |
| Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment. | Baseline and Week 12 |
| Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm. | Baseline and Week 12 |
| Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12 | The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am. | Baseline and Week 12 |
| Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm. | Baseline and Week 12 |
| Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am. | Baseline and Week 12 |
| Change From Baseline in 24-hour Blood Pressure Variability at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated. | Baseline and Week 12 |
| Blood Pressure Response Rate | Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100. | Week 12 |
| Heart Rate Response Rate | Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100. | Week 12 |
| Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated. | Baseline and Week 12 |
| Physician Decision |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Other |
|
| BG001 | Metoprolol | Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
| OG001 | Metoprolol | Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. |
|
|
| Primary | Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | beats/min | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12 | The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | beats/min | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | beats/min | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in 24-hour Blood Pressure Variability at Week 12 | The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Blood Pressure Response Rate | Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100. | ITT analysis population included all randomized subjects. 'N' (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. | Posted | Number | percentage of subjects | Week 12 |
|
|
|
| Secondary | Heart Rate Response Rate | Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100. | ITT analysis population included all randomized subjects. 'N' (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. | Posted | Number | percentage of subjects | Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12 | Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated. | ITT analysis population included all randomized subjects. 'n' signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively. | Posted | Mean | Standard Deviation | beats/min | Baseline and Week 12 |
|
|
|
| 2 |
| 93 |
| 17 |
| 93 |
| EG001 | Metoprolol | Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. | 0 | 93 | 16 | 93 |
| Transient attack | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ventricular premature contraction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High alanine aminotransferase | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High serum cholesterol level | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High blood glucose | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High blood triglycerides level | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High serum uric acid level | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Low high-density lipoprotein level | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| High low-density lipoprotein level | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urine leucocyte (positive) | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urine protein (positive) | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| DBP: Baseline (n=92, 93) |
|
| DBP: Change at Week 12 (n=68, 67) |
|
| DBP: Baseline (n=92, 93) |
|
| DBP: Change at Week 12 (n=68, 67) |
|
| DBP: Baseline (n=92, 93) |
|
| DBP: Change at Week 12 (n=68, 66) |
|
| DBP variability: Baseline (n=91, 92) |
|
| DBP variability: Change at Week 12 (n=66, 66) |
|