Trial Outcomes & Findings for Comparative Effects of Aspirin and NHP-544C (NCT NCT02189122)
NCT ID: NCT02189122
Last Updated: 2016-07-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
24 hour collection
Results posted on
2016-07-12
Participant Flow
Twenty-five enrolled participants were excluded prior to randomization to study group because they did not meet inclusion or exclusion criteria.
Participant milestones
| Measure |
Group 1:Aspirin/Placebo
Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg.
|
Group 2:NHP-544C/Placebo
Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effects of Aspirin and NHP-544C
Baseline characteristics by cohort
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
11-dehydrothromboxane B2
|
0.180 ng/mg creatinine
n=5 Participants
|
.214 ng/mg creatinine
n=7 Participants
|
.206 ng/mg creatinine
n=5 Participants
|
|
2,3-dinor-6-keto-PGF1alpha
|
.1 ng/mg creatinine
n=5 Participants
|
.139 ng/mg creatinine
n=7 Participants
|
.121 ng/mg creatinine
n=5 Participants
|
|
Age, Continuous
|
27.4 years
n=5 Participants
|
26.5 years
n=7 Participants
|
27.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hour collectionOutcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose
|
0.181 ng/mg creatinine
Interval 0.143 to 0.216
|
0.255 ng/mg creatinine
Interval 0.219 to 0.322
|
PRIMARY outcome
Timeframe: 24 hour collectionOutcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose
|
0.0685 ng/mg creatinine
Interval 0.0585 to 0.0717
|
0.115 ng/mg creatinine
Interval 0.095 to 0.155
|
PRIMARY outcome
Timeframe: 24 hour collectionOutcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose
|
0.054 ng/mg creatinine
Interval 0.043 to 0.077
|
0.071 ng/mg creatinine
Interval 0.056 to 0.115
|
PRIMARY outcome
Timeframe: 24 hour collectionOutcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose
|
0.102 ng/mg creatinine
Interval 0.083 to 0.116
|
0.144 ng/mg creatinine
Interval 0.128 to 0.194
|
PRIMARY outcome
Timeframe: 24 hour collectionOutcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose
|
0.069 ng/mg creatinine
Interval 0.049 to 0.116
|
0.128 ng/mg creatinine
Interval 0.105 to 0.161
|
PRIMARY outcome
Timeframe: 24 hour collectionPopulation: Data are given for 162.5 mg study day
Outcome measures
| Measure |
Group 1:Aspirin/Placebo
n=18 Participants
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 Participants
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose
|
0.067 ng/mg creatinine
Interval 0.045 to 0.104
|
0.108 ng/mg creatinine
Interval 0.084 to 0.16
|
Adverse Events
Group 1:Aspirin/Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2:NHP-544C/Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1:Aspirin/Placebo
n=18 participants at risk
Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
|
Group 2:NHP-544C/Placebo
n=18 participants at risk
Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
|
|---|---|---|
|
Cardiac disorders
ST T wave changes following bradykinin infusion
|
11.1%
2/18 • Number of events 2
|
16.7%
3/18 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus or nasal congestion
|
22.2%
4/18 • Number of events 4
|
16.7%
3/18 • Number of events 3
|
|
Hepatobiliary disorders
low albumin
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
Additional Information
Nancy J. Brown, M.D.
VANDERBILT UNIVERSITY MEDICAL CENTER
Phone: 6153438701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place