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Comparative Effects of Aspirin and NHP-544C
Plain-language guide to NCT02189122: not phased randomized trial of Bradykinin, 61 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02189122
- Phase
- not phased
- Status
- completed
- Start
- 2014-07
- Completion (planned or actual)
- 2015-07
- Participants
- 61 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Bradykinin.
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.
It had two arms (groups): Group 1:Aspirin/placebo (active comparator) and Group 2:NHP-544C/placebo (active comparator).
The registry classes the interventions as drug.
Who Took Part
61 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Ages of 18 and 55 years, inclusive. Body mass index (BMI) between 18.0 and 30.0kg/m2 (weight (kg)/\[height(m)\]2). Ability to understand the requirements of the study and a willingness to comply with all study procedures.
The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: participation in an investigational drug study within the 30 days prior to crc admission; history of metabolic, renal, hepatic, hemorrhagic stroke, gastrointestinal bleed, cardiovascular disease, central nervous system disorder, or peptic ulcer disease or other chronic bleeding disorder; history of gastrointestinal disorder that could result in incomplete absorption of the study drug.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Bradykinin group and the comparison group should start out alike.
The Bradykinin group and the comparison group ran side by side rather than switching.
As a double-blind Bradykinin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2014-07 with completion listed for 2015-07.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Bradykinin in 61 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Bradykinin compound page, all human trials.
Our Notes on the Compound
Bradykinin: A 9-amino-acid peptide that widens blood vessels and causes swelling; given in research studies of blood flow.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.