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Comparative Effects of Aspirin and NHP-544C

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ClinicalTrials.gov Identifier: NCT02189122
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 3, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Bradykinin
Drug: Aspirin 81 mg
Drug: Aspirin 162 mg
Drug: NHP544-C 81 mg
Drug: NHP544C 162 mg
Drug: Placebo
Enrollment 61
Recruitment Details  
Pre-assignment Details Twenty-five enrolled participants were excluded prior to randomization to study group because they did not meet inclusion or exclusion criteria.
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
27.4
(24.2 to 33.6)
26.5
(24.1 to 28.4)
27.1
(24.1 to 33.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
8
  44.4%
13
  72.2%
21
  58.3%
Male
10
  55.6%
5
  27.8%
15
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Hispanic or Latino
3
  16.7%
1
   5.6%
4
  11.1%
Not Hispanic or Latino
15
  83.3%
17
  94.4%
32
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  16.7%
3
   8.3%
White
18
 100.0%
14
  77.8%
32
  88.9%
More than one race
0
   0.0%
1
   5.6%
1
   2.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
11-dehydrothromboxane B2  
Median (Inter-Quartile Range)
Unit of measure:  Ng/mg creatinine
Number Analyzed 18 participants 18 participants 36 participants
0.180
(0.158 to .240)
.214
(.191 to .296)
.206
(.172 to .272)
2,3-dinor-6-keto-PGF1alpha  
Median (Inter-Quartile Range)
Unit of measure:  Ng/mg creatinine
Number Analyzed 18 participants 18 participants 36 participants
.1
(.089 to .139)
.139
(.117 to .252)
.121
(.095 to .158)
1.Primary Outcome
Title Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.181
(0.143 to 0.216)
0.255
(0.219 to 0.322)
2.Primary Outcome
Title Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.0685
(0.0585 to 0.0717)
0.115
(0.095 to 0.155)
3.Primary Outcome
Title Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.054
(0.043 to 0.077)
0.071
(0.056 to 0.115)
4.Primary Outcome
Title Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.102
(0.083 to 0.116)
0.144
(0.128 to 0.194)
5.Primary Outcome
Title Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.069
(0.049 to 0.116)
0.128
(0.105 to 0.161)
6.Primary Outcome
Title Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose
Hide Description [Not Specified]
Time Frame 24 hour collection
Hide Outcome Measure Data
Hide Analysis Population Description
Data are given for 162.5 mg study day
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: ng/mg creatinine
0.067
(0.045 to 0.104)
0.108
(0.084 to 0.160)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Hide Arm/Group Description

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 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.

All-Cause Mortality
Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1:Aspirin/Placebo Group 2:NHP-544C/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/18 (38.89%)      6/18 (33.33%)    
Cardiac disorders     
ST T wave changes following bradykinin infusion   2/18 (11.11%)  2 3/18 (16.67%)  3
Hepatobiliary disorders     
low albumin   1/18 (5.56%)  1 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders     
Sinus or nasal congestion   4/18 (22.22%)  4 3/18 (16.67%)  3
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nancy J. Brown, M.D.
Organization: VANDERBILT UNIVERSITY MEDICAL CENTER
Phone: 6153438701
Responsible Party: Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02189122     History of Changes
Other Study ID Numbers: 140707
First Submitted: July 10, 2014
First Posted: July 14, 2014
Results First Submitted: March 18, 2016
Results First Posted: June 3, 2016
Last Update Posted: July 12, 2016