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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

Adequately controlled hypertension, with diastolic blood pressure ≤100 mmHg at screening

Be older than 18 years old

Must not have

Female subjects who are pregnant or nursing a child

Has taken any prescription medication other than hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), thyroid replacement hormones, anti-hyperlipidemic agents, or anti-hypertensive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-48 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My high blood pressure is under control, with a diastolic reading of 100 mmHg or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I am only taking medication for hormone replacement, thyroid, cholesterol, or blood pressure.

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I have taken blood thinners or anti-platelet medications before.

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I am willing to provide a blood sample for genetic testing.

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I have a history of stomach or intestinal problems, including ulcers.

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I have a blood disorder affecting clotting or bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure [mmHg]

Secondary study objectives

Mean arterial pressure (MAP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 4

~1070

0 / 7Eligibility criteria met