Trial Outcomes & Findings for AMP as a Better Delivery System of Adenosine (NCT NCT00179010)
NCT ID: NCT00179010
Last Updated: 2019-05-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)
Results posted on
2019-05-07
Participant Flow
Subjects were recruited through mass e-mails and flyers posted in campus
Subjects were randomly assigned to each treatment arm, after being screened for any medical problem that would be considered a contraindication for the study according to the physician performing the initial evaluation. Once subjects completed one arm, they were crossed to the other arm and studied at lest one month after.
Participant milestones
| Measure |
Adenosine First Then AMP
Intrarterial infusion of adenosine first
Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Subjects in this group were assigned to received intrarterial infusions of adenosine and then crossed to the other arm (AMP) after at least 1 month.
|
Adenosine Mono Phosphate (AMP) First Then Adenosine
Intrarterial infusion of AMP first
Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Subjects intros group were assigned to received intrarterial infusions of AMP and then crossed to the other arm (adenosine), at least 1 month after.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Adenosine First Then AMP
Intrarterial infusion of adenosine first
Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Subjects in this group were assigned to received intrarterial infusions of adenosine and then crossed to the other arm (AMP) after at least 1 month.
|
Adenosine Mono Phosphate (AMP) First Then Adenosine
Intrarterial infusion of AMP first
Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Subjects intros group were assigned to received intrarterial infusions of AMP and then crossed to the other arm (adenosine), at least 1 month after.
|
|---|---|---|
|
Overall Study
Muscle probe defective
|
1
|
1
|
|
Overall Study
Failure to place arterial line
|
0
|
1
|
Baseline Characteristics
AMP as a Better Delivery System of Adenosine
Baseline characteristics by cohort
| Measure |
Adenosine Mono Phosphate (AMP) First
n=7 Participants
Intrarterial infusion of AMP
Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
|
Adenosine First
n=6 Participants
Intrarterial infusion of adenosine
Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10 • n=5 Participants
|
37 years
STANDARD_DEVIATION 10 • n=7 Participants
|
37 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)Population: 13 subjects received both treatments. 3 subject did not complete the study and were excluded. We are reporting data in only 10 subjects that have collected samples.
Outcome measures
| Measure |
Adenosine
n=10 Participants
Intrarterial infusion of adenosine
Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
|
Adenosine Mono Phosphate (AMP)
n=10 Participants
Intra-arterial infusion of AMP
|
|---|---|---|
|
Interstitial Adenosine Levels
First Dose
|
89.8 nM
Standard Error 18.6
|
86.2 nM
Standard Error 13.9
|
|
Interstitial Adenosine Levels
Third dose
|
93.2 nM
Standard Error 15.7
|
91.7 nM
Standard Error 13.8
|
|
Interstitial Adenosine Levels
Second Dose
|
87.5 nM
Standard Error 12.7
|
91.1 nM
Standard Error 18.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)Population: This was an exploratory Outcome and was abandoned.
Outcome measures
Outcome data not reported
Adverse Events
Adenosine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adenosine Mono Phosphate (AMP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Italo Biaggioni, MD., Professor of Medicine and Pharmacology
Vanderbilt University
Phone: (615) 936-3420
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place