Aspirin + Celecoxib for Blood Pressure Control

Overseen by Carsten Skarke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Research Team

Carsten Skarke, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

Total cholesterol of ≤270 mg/dL

Body mass index (BMI) between 18 and 30 kg/m2

Exclusion 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.

Volunteers enrolled in the sub-study who do not own a smartphone

Treatment Details

Interventions

• Aspirin (Nonsteroidal Anti-inflammatory Drug)
• Celecoxib (Nonsteroidal Anti-inflammatory Drug)

Trial Overview 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.

Participant Groups

Group I: Celecoxib 200mg capsule Experimental Treatment 2 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/Placebo Experimental Treatment 2 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.

Aspirin is already approved in Canada, China for the following indications:

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+