Trial Outcomes & Findings for The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317) (NCT NCT00943852)
NCT ID: NCT00943852
Last Updated: 2022-02-09
Results Overview
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Baseline and 10 hours postdose
Results posted on
2022-02-09
Participant Flow
First Patient Entered: 31-Aug-2006 Last Patient Last Visit: 11-Dec-2006 Number of Sites: 1
Participant milestones
| Measure |
Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN
Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN
Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
|
ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN
ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo
Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan
Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
|
Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN
Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
|
Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN
Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo
ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan
Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN
Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
|---|---|---|---|---|---|---|---|---|---|---|
|
First Period of Treatment Intervention
STARTED
|
2
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
|
First Period of Treatment Intervention
COMPLETED
|
2
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
|
First Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 1 Treatment
STARTED
|
2
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Washout Period After Period 1 Treatment
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Washout Period After Period 1 Treatment
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Period of Treatment Intervention
STARTED
|
2
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Second Period of Treatment Intervention
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Second Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 2 Treatment
STARTED
|
2
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
|
Washout Period After Period 2 Treatment
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
|
Washout Period After Period 2 Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Third Period of Treatment Intervention
STARTED
|
2
|
1
|
1
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
|
Third Period of Treatment Intervention
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
|
Third Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 3 Treatment
STARTED
|
2
|
1
|
1
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
|
Washout Period After Period 3 Treatment
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Washout Period After Period 3 Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Fourth Period of Treatment Intervention
STARTED
|
2
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Fourth Period of Treatment Intervention
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Fourth Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 4 Treatment
STARTED
|
2
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Washout Period After Period 4 Treatment
COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Washout Period After Period 4 Treatment
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Fifth Period of Treatment Intervention
STARTED
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Fifth Period of Treatment Intervention
COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Fifth Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN
Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN
Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
|
ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN
ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo
Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan
Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
|
Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN
Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
|
Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN
Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo
ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan
Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
|
Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN
Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Washout Period After Period 1 Treatment
BP too low for dosing at the next period
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 2 Treatment
Trial stopped early
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period After Period 3 Treatment
Did not meet criteria for next period
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period After Period 4 Treatment
Not taking medication per protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period After Period 4 Treatment
Trial stopped early
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
Baseline characteristics by cohort
| Measure |
All Participants in Study
n=13 Participants
|
|---|---|
|
Age, Continuous
|
57.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Exclusionary Medication Washout
Yes
|
3 participants
n=5 Participants
|
|
Exclusionary Medication Washout
No
|
10 participants
n=5 Participants
|
|
Diastolic Blood Pressure
|
90.6 mm Hg
n=5 Participants
|
|
Heart Rate
|
75.4 Beats per Minute
n=5 Participants
|
|
Systolic Blood Pressure
|
141.5 mm Hg
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 10 hours postdosePopulation: All subjects who received single doses of losartan 100 mg + ISMN 60 mg and/or single dose of losartan 100 mg
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Outcome measures
| Measure |
Losartan 100 mg + ISMN 60 mg
n=8 Participants
|
Losartan 100 mg
n=10 Participants
|
|---|---|---|
|
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg
|
-24.9 Percent Change
Standard Deviation 3.8
|
-1.8 Percent Change
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Baseline and 10 hours postdosePopulation: All subjects who received single doses of Losartan 100 mg + ISMN 60 mg and/or single dose of placebo
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Outcome measures
| Measure |
Losartan 100 mg + ISMN 60 mg
n=8 Participants
|
Losartan 100 mg
n=8 Participants
|
|---|---|---|
|
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo
|
-24.9 Percent Change
Standard Deviation 3.8
|
-1.3 Percent Change
Standard Deviation 3.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Losartan 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Losartan 100 mg + ISMN 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Losartan 100 mg + ISMN 60 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ISMN 60 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
|
Losartan 100 mg
n=11 participants at risk
|
Losartan 100 mg + ISMN 15 mg
n=13 participants at risk
|
Losartan 100 mg + ISMN 60 mg
n=11 participants at risk
|
ISMN 60 mg
n=12 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
9.1%
1/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
9.1%
1/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
8.3%
1/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
7.7%
1/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
7.7%
1/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
9.1%
1/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
8.3%
1/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
9.1%
1/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
18.2%
2/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
25.0%
3/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
9.1%
1/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/13 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
27.3%
3/11 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
0.00%
0/12 • Run-in period through 14 days post last dose of study drug (documented by telephone contact or in person)
One (1) of the 13 enrolled subjects completed one period of the study and (1) of the 13 enrolled subjects completed 2 periods of the study prior to termination of the study. These subjects were included in the AE summary tables having been exposed to treatment, but were not included in the statistical analysis.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER