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TUDCA for High Blood Pressure

Phase 1 & 2

Recruiting

Research Sponsored by University of North Texas Health Science Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 80 years of age

No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1-2 weeks before and after intervention or placebo

Awards & highlights

Study Summary

This trial will explore how ER stress contributes to hypertension in humans, to inform the development of new treatments.

Who is the study for?

This trial is for adults aged 18-80 with high blood pressure who are non-smokers, not pregnant, and have a BMI under 35. They must have normal heart health as shown by an ECG and cannot be on certain medications like beta blockers or blood thinners. People with serious health issues such as uncontrolled heart rhythm problems, recent concussions, drug abuse history, cancer, severe allergies including latex or needle phobia are excluded.Check my eligibility

What is being tested?

The study tests TUDCA (a compound thought to reduce stress in cells) against a placebo to see if it can help manage hypertension in humans. Participants won't know which they're receiving in this single-blind setup where the researchers but not the subjects know what treatment is being given.See study design

What are the potential side effects?

While specific side effects of TUDCA aren't listed here, common ones may include digestive discomforts like nausea or diarrhea. Placebos typically don't cause side effects but some individuals might experience symptoms due to their expectations of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I haven't used tobacco or nicotine products in the last 6 months.

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I am a woman and have a negative pregnancy test or am post-menopausal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1-2 weeks before and after intervention or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1-2 weeks before and after intervention or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1-2 weeks before and after intervention or placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

24 hour Blood Pressure

Secondary outcome measures

Arterial Pulse Wave Velocity

Cardiac output

Endoplasmic Reticulum Stress

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Endoplasmic Reticulum Stress InhibitionExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Texas Health Science CenterLead Sponsor

39 Previous Clinical Trials

20,102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants under the age of thirty-five?

"The eligibility criteria for this clinical trial allows people aged 18 and up to 80 years old to participate."

Answered by AI

Is enrollment for this experiment accessible to participants yet?

"Confirmed. Clinicaltrials.gov displays this trial as active, with the initial posting date being August 15th 2023 and most recent edit taking place on August 29th of the same year."

Answered by AI

Is there an opportunity for me to join this research program?

"This study requires that potential participants have elevated blood pressure and be situated within the 18-80 age bracket. Approximately 70 people are anticipated to join in this trial."

Answered by AI

Could you provide an approximate figure as to how many individuals are partaking in this trial?

"Affirmative. Clinicaltrials.gov holds a record of this investigation, which was initially uploaded on August 15th 2023 and amended on the 29th of that same month. Aspiring participants are being recruited from 1 location with the goal of enlisting 70 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeting Endoplasmic Reticulum Stress in Human Hypertension

Steven Romero 2023. "Targeting Endoplasmic Reticulum Stress in Human Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06025630.