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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCP | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine the effect of LY2216684 on heart rate and blood pressure in research participants with MDD who are being treated with an SSRI (selective serotonin reuptake inhibitors). Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 24 days not including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18 mg LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four single daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2216684, placebo, LY or placebo | Experimental | Period 1: 18 milligrams (mg) LY2216684 administered orally once daily on Days 1-4 Period 2: placebo administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4 |
|
| Placebo, LY2216684, placebo or LY | Experimental | Period 1: placebo administered orally once daily on Days 1-4 Period 2: 18 mg LY2216684 administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1 | Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 1 |
| Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4 | Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1 | Blood pressure (BP) was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 1. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Louis | Missouri | 63118 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18-mg LY2216684; Placebo; 36-mg LY2216684 or Placebo | Period 1: 18-milligram (mg) LY2216684 (LY) administered orally once daily on Days 1-4 Period 2: Placebo administered orally, once daily on Days 1-4 Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4 |
| FG001 | Placebo; 18-mg LY2216684; Placebo or 36-mg LY2216684 | Period 1: Placebo administered orally, once daily on Days 1-4 Period 2: 18-mg LY2216684 administered orally, once daily on Days 1-4 Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| 3-Day Washout |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
| |||||||||||||
| 7-day Follow-up |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | Period 1: 18-mg LY2216684 or Placebo administered orally, once daily on Days 1-4. Period 2: Participants who received LY2216684 in Period 1, then received Placebo administered orally, once daily on Days 1-4 in Period 2. Participants who received Placebo in Period 1, then received 18-mg LY2216684 administered orally, once daily on Days 1-4 in Period 2. Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4. |
| 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 | Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1 | Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (bpm) | Baseline through the 24-hour interval on Day 1 | Observations | Observations |
|
Periods 1, 2, and 3 through 7-day follow-up
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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 | 18-mg LY2216684 | Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568831 | alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol |
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| Placebo | Drug | Administered orally |
|
| Baseline through the 24-hour interval on Day 1 |
| Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4 | Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4 | Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | Baseline through the 24-hour interval on Day 4 |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78731 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | 18-mg LY2216684 | Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days. |
| OG001 | Placebo | Participants received a single, oral dose of Placebo each day over 4 days. |
|
|
|
| Secondary | Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1 | Blood pressure (BP) was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 1. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | millimeter of mercury (mm Hg) | Baseline through the 24-hour interval on Day 1 | Observations | Observations |
|
|
|
|
| Secondary | Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | millimeter of mercury (mm Hg) | Baseline through the 24-hour interval on Day 4 | Observations | Observations |
|
|
|
|
| Secondary | Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4 | Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (bpm) | Baseline through the 24-hour interval on Day 4 | Observations | Observations |
|
|
|
|
| Secondary | Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | millimeter of mercury (mm Hg) | Baseline through the 24-hour interval on Day 4 | Observations | Observations |
|
|
|
|
| Secondary | Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4 | Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (bpm) | Baseline through the 24-hour interval on Day 4 |
|
|
|
|
| Primary | Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4 | Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 were made in Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (bpm) | Baseline through the 24-hour interval on Day 4 | Observations | Observations |
|
|
|
|
| Secondary | Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4 | BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect. | All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. | Posted | Least Squares Mean | 90% Confidence Interval | millimeter of mercury (mm Hg) | Baseline through the 24-hour interval on Day 4 |
|
|
|
|
| 0 |
| 24 |
| 20 |
| 24 |
| EG001 | 36-mg LY2216684 | Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days. | 1 | 19 | 12 | 19 |
| EG002 | Placebo | Participants received a single, oral dose of Placebo each day over 4 days. | 0 | 24 | 14 | 24 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| Mean Change, Diastolic BP |
|
| Maximum Change, Diastolic BP |
|
| 0.0025 |
P-value is for the Maximum Change in ABPM systolic BP. |
| Mean Difference (Final Values) |
| 7.1 |
| 2-Sided |
| 95 |
| 2.6 |
| 11.6 |
| Superiority or Other |
| Mixed Models Analysis | <0.0001 | P-value is for the Mean Change in ABPM diastolic BP. | Mean Difference (Final Values) | 5.51 | 2-Sided | 95 | 3.81 | 7.21 | Superiority or Other |
| Mixed Models Analysis | 0.0020 | P-value is for the Maximum Change in ABPM diastolic BP. | Mean Difference (Final Values) | 5.66 | 2-Sided | 95 | 2.13 | 9.20 | Superiority or Other |
| Mean Change, Diastolic BP |
|
| Maximum Change, Diastolic BP |
|
| 0.2453 |
P-value is for the Maximum Change in ABPM systolic BP. |
| Mean Difference (Final Values) |
| 2.70 |
| 2-Sided |
| 95 |
| -1.88 |
| 7.29 |
| Superiority or Other |
| Mixed Models Analysis | <0.0001 | P-value if for the Mean Change in ABPM diastolic BP. | Mean Difference (Final Values) | 5.10 | 2-Sided | 95 | 3.37 | 6.82 | Superiority or Other |
| Mixed Models Analysis | 0.0005 | P-value is for the Maximum Change in ABPM diastolic BP. | Mean Difference (Final Values) | 6.53 | 2-Sided | 95 | 2.95 | 10.1 | Superiority or Other |
| 0.0001 |
P-value is for the Maximum Change in ABPM heart rate. |
| Mean Difference (Final Values) |
| 23.0 |
| 2-Sided |
| 95 |
| 11.4 |
| 34.5 |
| Superiority or Other |
| Mean Change, Diastolic BP |
|
| Maximum Change, Diastolic BP |
|
| 0.0640 |
P-value is for the Maximum Change in ABPM Systolic BP. |
| Mean Difference (Final Values) |
| 7.6 |
| 2-Sided |
| 95 |
| -0.4 |
| 15.5 |
| Superiority or Other |
| Mixed Models Analysis | 0.0211 | P-value is for the Mean Change in ABPM Diastolic BP. | Mean Difference (Final Values) | 3.6 | 2-Sided | 95 | 0.5 | 6.7 | Superiority or Other |
| Mixed Models Analysis | 0.8719 | P-value is for the Maximum Change in ABPM Diastolic BP. | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -5.7 | 6.8 | Superiority or Other |
| 0.4638 |
P-value is for the Maximum Change in ABPM heart rate. |
| Mean Difference (Final Values) |
| -4.7 |
| 2-Sided |
| 95 |
| -17.2 |
| 7.9 |
| Superiority or Other |
| <0.0001 |
P-value is for the Maximum Change in ABPM heart rate. |
| Mean Difference (Final Values) |
| 27.6 |
| 2-Sided |
| 95 |
| 21.1 |
| 34.2 |
| Superiority or Other |
| Mean Change, Diastolic BP |
|
| Maximum Change, Diastolic BP |
|
| 0.2731 |
P-value is for the Maximum Change in ABPM Systolic BP. |
| Mean Difference (Final Values) |
| 4.8 |
| 2-Sided |
| 95 |
| -3.9 |
| 13.6 |
| Superiority or Other |
| Mixed Models Analysis | 0.3779 | P-value is for the Mean Change in ABPM Diastolic BP. | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -4.8 | 1.8 | Superiority or Other |
| Mixed Models Analysis | 0.0828 | P-value is for the Maximum Change in ABPM Diastolic BP. | Mean Difference (Final Values) | -6.0 | 2-Sided | 95 | -12.8 | 0.8 | Superiority or Other |