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Nonsteroidal Anti-inflammatory Drug
Aspirin + Celecoxib for Blood Pressure Control
Phase < 1
Waitlist Available
Led By Carsten Skarke, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women greater than 18 years of age
Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours
Awards & highlights
Study Summary
This trial will test whether taking aspirin at the same time as celecoxib can help to lower blood pressure.
Who is the study for?
This trial is for healthy adults over 18 who don't smoke, drink moderately, and have a BMI between 18-30. Women must use contraception and not be pregnant or nursing. Participants can't have bleeding disorders, allergies to aspirin or celecoxib, recent drug trials participation, significant health issues, or take certain medications.Check my eligibility
What is being tested?
The study tests if taking aspirin at specific times lessens the impact of celecoxib on blood pressure in healthy individuals. It involves administering low-dose aspirin with celecoxib capsules under controlled conditions to monitor their effects.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding due to aspirin's blood-thinning properties and gastrointestinal issues like ulcers from both drugs. Celecoxib may also cause allergic reactions and raise blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I haven't used tobacco or nicotine products for at least 3 months.
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I am in good health according to recent medical exams and tests.
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My high blood pressure is under control, with a diastolic reading of 100 mmHg or less.
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I haven't used tobacco or nicotine products for at least 3 months.
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I can avoid alcohol 48 hours before and during the study.
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I can avoid alcohol 48 hours before and during the study until the last visit.
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I am using birth control as a woman who can still have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure [mmHg]
Secondary outcome measures
Mean arterial pressure (MAP)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Celecoxib 200mg capsuleExperimental Treatment2 Interventions
Participants will receive celecoxib in Phase 1 and Phase 2 over 7 days. This is open, meaning participant and investigator will recognize celecoxib capsules.
Group II: Aspirin 81 mg/PlaceboExperimental Treatment2 Interventions
Participants will receive aspirin in Phase 1 followed by matched placebo in Phase 2, or vice versa, over 14 days. The order will be randomized and aspirin/placebo will be double-blinded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 81 mg
2007
Completed Phase 4
~810
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,028 Total Patients Enrolled
Carsten Skarke, MDPrincipal InvestigatorUniversity of Pennsylvania
7 Previous Clinical Trials
192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken NSAIDs or stomach acid reducers in the last 2 weeks.You have had problems with drugs or alcohol in the past 6 months.I am over 18 years old.I haven't used tobacco or nicotine products for at least 3 months.Can understand and follow the instructions for the study.I am currently pregnant or breastfeeding.A BMI of 18-30 kg/m2 is considered normal weight.I am only taking medication for hormone replacement, thyroid, cholesterol, or blood pressure.I have taken blood thinners or anti-platelet medications before.I am in good health according to recent medical exams and tests.My high blood pressure is under control, with a diastolic reading of 100 mmHg or less.You are allergic to aspirin or other medications called NSAIDs.I am willing to provide a blood sample for genetic testing.I haven't taken supplements like Vitamin E or fish oil in the last 14 days.You are allergic to celecoxib (Celebrex) or aspirin.I haven't used tobacco or nicotine products for at least 3 months.I can avoid alcohol 48 hours before and during the study.Subjects must consent to provide a urine sample for drug and nicotine testing as part of the screening processOn average, does not consume more than one alcoholic beverage per day.I can avoid alcohol 48 hours before and during the study until the last visit.I have a history of stomach or intestinal problems, including ulcers.I am using birth control as a woman who can still have children.I have a blood disorder affecting clotting or bleeding.I haven't had cancer in the last 5 years, except for certain skin cancers or treated cervical cancer.I do not have a history of major heart, kidney, liver, lung (except old infections), immune, hormone, blood, or nerve diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Aspirin 81 mg/Placebo
- Group 2: Celecoxib 200mg capsule
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently enrolled in the research?
"This research has stopped recruiting, with postings going up on December 1st 2022 and the final update being made in June 13th 2022. Nevertheless, there are still 845 clinical trials targeting healthy subjects (hs) as well as 206 studies for Aspirin 81 mg that require participants."
Answered by AI
Are there any unfilled vacancies for participants in this research trial?
"Currently, this medical trial is not in a period of recruitment. Originally posted on December 1st 2022 and last updated June 13th 2021, the study has yet to open enrollment again. If you're searching for other trials, 845 studies are actively looking for participants with healthy subjects (HS) while 206 clinical trials are admitting enrollees into Aspirin 81 mg studies."
Answered by AI
What conditions can be remedied with a daily dose of Aspirin 81 mg?
"Aspirin 81 mg is typically prescribed to aid with percutaneous coronary interventions (pci). It can also be used for other treatments such as relieving dental pain, reducing joint inflammation, and alleviating neck aches."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania: < 24 hours
Average response time
- < 1 Day
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