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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCI | 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 of participants receiving Albuterol and Propranolol. Information about any side effects that may occur will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2216684, albuterol, LY2216684+albuterol | Experimental | LY2216684 as an 18 milligram (mg) oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in first intervention period, placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a minimum 7 day washout between each intervention period. |
|
| albuterol, LY2216684+albuterol, LY2216684 | Experimental | Placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in third intervention period. There is a minimum 7 day washout between each intervention period. |
|
| LY2216684+albuterol, LY2216684, albuterol | Experimental | LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in second intervention period, Placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a minimum 7 day washout between each intervention period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum, Minimum and Average Changes in Heart Rate | Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. | Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum, Minimum and Average Changes in Systolic Blood Pressure | Systolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline systolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose systolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose systolic blood pressure for a day was the average systolic blood pressure for 24 hours. The least squares (LS) mean change from baseline systolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. |
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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. | Evansville | Indiana |
This was a 3-period, crossover study conducted in 2 groups. Participants were randomized to 1 of 3 sequences in either the albuterol group (Group 1) or 1 of 3 sequences in the propranolol group (Group 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1, Seq 1: LY2216684, Albuterol, LY2216684+Albuterol | Group 1, Sequence (Seq) 1 First intervention: LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5. Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| FG001 | Group 1, Seq 2: Albuterol, LY2216684+Albuterol, LY2216684 | Group 1, Sequence 2 First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| FG002 | Group 1, Seq 3: LY2216684+Albuterol, LY2216684, Albuterol | Group 1, Sequence 3 First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5. Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| FG003 | Group 2, Seq 1: LY2216684, Propranolol, LY2216684+Propranolol | Group 2, Sequence 1 First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5. Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| FG004 | Group 2, Seq 2: Propranolol, LY2216684+Propranolol, LY2216684 | Group 2, Sequence 2 First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| FG005 | Group 2, Seq 3: LY2216684+Propranolol, LY2216684, Propranolol | Group 2, Sequence 3 First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5. Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5. There was a minimum 7-day washout between each intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Period 1) |
|
| ||||||||||||||||||
| Washout Period 1 |
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| Second Intervention (Period 2) |
| |||||||||||||||||||
| Washout Period 2 |
| |||||||||||||||||||
| Third Intervention (Period 3) |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1, Any Sequence (LY2216684, Albuterol, or Placebo) | Participants were administered LY2216684, albuterol, or placebo during Periods 1, 2, and 3. LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 of each period. Albuterol or placebo was co-administered as a 2-mg oral dose (one 2-mg tablet) QD on Days 1, 3, and 5 of each period. |
| 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, Minimum and Average Changes in Heart Rate | Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. | Randomized participants with at least 1 postdose heart rate measurement. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (bpm) | Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose) |
|
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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 | LY2216684 (Group 1) | Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac 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 |
| D000420 | Albuterol |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| LY2216684, propranolol, LY2216684+propranolol | Experimental | LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in first intervention period, placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a minimum 7 day washout between each intervention period. |
|
| propranolol, LY2216684+propranolol, LY2216684 | Experimental | Placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in third intervention period. There is a minimum 7 day washout between each intervention period. |
|
| LY2216684+propranolol, LY2216684, propranolol | Experimental | LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in second intervention period, placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a minimum 7 day washout between each intervention period. |
|
| albuterol | Drug | administered orally |
|
| propranolol | Drug | administered orally |
|
| placebo for LY2216684 | Drug | administered orally |
|
| placebo for albuterol | Drug | administered orally |
|
| placebo for propranolol | Drug | administered orally |
|
| Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours) |
| Maximum, Minimum and Average Changes in Diastolic Blood Pressure | Diastolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline diastolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose diastolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose diastolic blood pressure for a day was the average diastolic blood pressure for 24 hours. The least squares (LS) mean change from baseline diastolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. | Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours) |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Group 2, Any Sequence (LY2216684, Propranolol, or Placebo) | Participants were administered LY2216684, propranolol, or placebo during Periods 1, 2, and 3. LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) QD on Days 1 through 5 of each period. Propranolol or placebo was co-administered as a 40-mg oral dose (one 40-mg tablet) QD on Days 1, 3, and 5 of each period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period. |
| OG001 | Albuterol | Participants randomized to Group 1 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. |
| OG002 | LY2216684+Albuterol | Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. |
| OG003 | LY2216684 (Group 2) | Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period. |
| OG004 | Propranolol | Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. |
| OG005 | LY2216684+Propranolol | Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. |
|
|
|
| Secondary | Maximum, Minimum and Average Changes in Systolic Blood Pressure | Systolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline systolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose systolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose systolic blood pressure for a day was the average systolic blood pressure for 24 hours. The least squares (LS) mean change from baseline systolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. | Randomized participants with at least 1 postdose systolic blood pressure measurement. | Posted | Least Squares Mean | 90% Confidence Interval | millimeters of mercury (mm Hg) | Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours) |
|
|
|
|
| Secondary | Maximum, Minimum and Average Changes in Diastolic Blood Pressure | Diastolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline diastolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose diastolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose diastolic blood pressure for a day was the average diastolic blood pressure for 24 hours. The least squares (LS) mean change from baseline diastolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction. | Randomized participants with at least 1 postdose diastolic blood pressure measurement. | Posted | Least Squares Mean | 90% Confidence Interval | millimeters of mercury (mm Hg) | Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours) |
|
|
|
|
| 0 |
| 24 |
| 13 |
| 24 |
| EG001 | Albuterol | Participants randomized to Group 1 who received who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. | 0 | 24 | 2 | 24 |
| EG002 | LY2216684+Albuterol | Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. | 0 | 24 | 13 | 24 |
| EG003 | LY2216684 (Group 2) | Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period. | 0 | 22 | 9 | 22 |
| EG004 | Propranolol | Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40-mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. | 0 | 22 | 8 | 22 |
| EG005 | LY2216684+Propranolol | Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period. | 0 | 22 | 13 | 22 |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chapped lips | 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 |
|
| Application site irritation | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Groin 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 |
|
| Memory impairment | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Penile discharge | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Penile size reduced | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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Not provided
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Day 1 Minimum Change |
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| Day 1 Average Change |
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| Day 3 Maximum Change |
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| Day 3 Minimum Change |
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| Day 3 Average Change |
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| Day 5 Maximum Change |
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| Day 5 Minimum Change |
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| Day 5 Average Change |
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Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.
| LS mean difference |
| 2.73 |
| 2-Sided |
| 95 |
| -1.38 |
| 6.85 |
| Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 2.67 | 2-Sided | 95 | -0.209 | 5.56 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 0.541 | 2-Sided | 95 | -2.94 | 4.02 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 5.26 | 2-Sided | 95 | 1.09 | 9.43 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 2.60 | 2-Sided | 95 | -0.322 | 5.52 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -6.46 | 2-Sided | 95 | -11.5 | -1.41 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | 0.171 | 2-Sided | 95 | -5.21 | 5.56 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -3.09 | 2-Sided | 95 | -6.73 | 0.557 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 1.46 | 2-Sided | 95 | -3.61 | 6.53 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 11.4 | 2-Sided | 95 | 5.99 | 16.8 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 7.15 | 2-Sided | 95 | 3.49 | 10.8 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 0.0309 | 2-Sided | 95 | -5.28 | 5.34 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -1.17 | 2-Sided | 95 | -5.93 | 3.59 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -0.333 | 2-Sided | 95 | -4.35 | 3.68 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | -2.11 | 2-Sided | 95 | -7.42 | 3.20 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 4.36 | 2-Sided | 95 | -0.404 | 9.12 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | -0.119 | 2-Sided | 95 | -4.14 | 3.90 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -4.16 | 2-Sided | 95 | -9.69 | 1.37 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -4.76 | 2-Sided | 95 | -10.2 | 0.718 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -4.20 | 2-Sided | 95 | -8.71 | 0.320 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 3.20 | 2-Sided | 95 | -2.34 | 8.74 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 3.95 | 2-Sided | 95 | -1.54 | 9.43 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 4.84 | 2-Sided | 95 | 0.319 | 9.37 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 2.34 | 2-Sided | 95 | -3.44 | 8.12 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 1.89 | 2-Sided | 95 | -3.22 | 7.00 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 1.83 | 2-Sided | 95 | -1.85 | 5.52 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 0.327 | 2-Sided | 95 | -5.45 | 6.10 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 3.18 | 2-Sided | 95 | -1.93 | 8.29 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 2.12 | 2-Sided | 95 | -1.56 | 5.81 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -1.60 | 2-Sided | 95 | -6.79 | 3.59 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -0.163 | 2-Sided | 95 | -5.00 | 4.68 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -0.829 | 2-Sided | 95 | -5.20 | 3.54 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 1.95 | 2-Sided | 95 | -3.27 | 7.17 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 3.71 | 2-Sided | 95 | -1.17 | 8.59 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 4.28 | 2-Sided | 95 | -0.103 | 8.67 | Superiority or Other |
| Day 1 Minimum Change |
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| Day 1 Average Change |
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| Day 3 Maximum Change |
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| Day 3 Minimum Change |
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| Day 3 Average Change |
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| Day 5 Maximum Change |
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| Day 5 Minimum Change |
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| Day 5 Average |
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Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.
| LS mean difference |
| 1.05 |
| 2-Sided |
| 95 |
| -1.91 |
| 4.02 |
| Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -0.199 | 2-Sided | 95 | -2.58 | 2.18 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 1.37 | 2-Sided | 95 | -1.34 | 4.07 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 3.68 | 2-Sided | 95 | 0.674 | 6.69 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 2.40 | 2-Sided | 95 | -0.0178 | 4.81 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -4.22 | 2-Sided | 95 | -7.83 | -0.619 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | 0.335 | 2-Sided | 95 | -4.45 | 5.12 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -1.92 | 2-Sided | 95 | -4.81 | 0.969 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 2.47 | 2-Sided | 95 | -1.15 | 6.10 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 9.12 | 2-Sided | 95 | 4.30 | 13.9 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 6.03 | 2-Sided | 95 | 3.12 | 8.94 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -0.913 | 2-Sided | 95 | -4.65 | 2.82 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -0.444 | 2-Sided | 95 | -4.33 | 3.44 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 0.378 | 2-Sided | 95 | -2.20 | 2.95 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 0.878 | 2-Sided | 95 | -2.86 | 4.62 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 2.92 | 2-Sided | 95 | -0.966 | 6.80 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 2.94 | 2-Sided | 95 | 0.366 | 5.52 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -2.88 | 2-Sided | 95 | -6.84 | 1.07 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -0.975 | 2-Sided | 95 | -5.39 | 3.44 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -1.82 | 2-Sided | 95 | -5.30 | 1.66 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 5.60 | 2-Sided | 95 | 1.63 | 9.56 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 7.82 | 2-Sided | 95 | 3.39 | 12.3 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 6.60 | 2-Sided | 95 | 3.11 | 10.1 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | 0.847 | 2-Sided | 95 | -3.23 | 4.92 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -3.48 | 2-Sided | 95 | -8.17 | 1.21 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm. | LS mean difference | -0.372 | 2-Sided | 95 | -2.88 | 2.14 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 1.90 | 2-Sided | 95 | -2.17 | 5.98 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 1.07 | 2-Sided | 95 | -3.62 | 5.76 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm. | LS mean difference | 3.03 | 2-Sided | 95 | 0.522 | 5.55 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | 0.737 | 2-Sided | 95 | -3.90 | 5.38 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -1.95 | 2-Sided | 95 | -6.36 | 2.47 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm. | LS mean difference | -1.17 | 2-Sided | 95 | -4.79 | 2.45 | Superiority or Other |
| Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 7.25 | 2-Sided | 95 | 2.59 | 11.9 | Superiority or Other |
| Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 5.58 | 2-Sided | 95 | 1.13 | 10.0 | Superiority or Other |
| Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm. | LS mean difference | 5.53 | 2-Sided | 95 | 1.89 | 9.16 | Superiority or Other |