Recruiting

Chlorthalidone & HCTZ

Sponsor:

Creighton University

Code:

NCT02100462

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

Aspirin 81 mg

Study Details

Brief summary:

This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.

Conditions

Hypertension

Study ID

NCT02100462

Start date

Mar, 2014

Status verified date

Dec, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men or women age 19 or older
  • Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements
  • No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period
  • Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg
  • Non-smoker

Exclusion Criteria:

  • Previous adverse reaction or allergy to HCTZ, CTD, or ASA
  • Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome)
  • Diagnosis of any chronic disease or condition
  • History of gout or hyperuricemia
  • History of pancreatitis
  • History of systemic lupus erythematosus (SLE)
  • History of hypokalemia requiring treatment
  • Pregnant or planning to become pregnant during the study period
  • Breastfeeding
  • History of hypotension
  • History of gastrointestinal bleeding

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chlorthalidone 12.5 mg

Chlorthalidone 12.5 mg by mouth once daily for 2 weeks

experimental: Hydrochlorothiazide 25 mg

Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

active comparator: Aspirin 81 mg

Aspirin 81 mg by mouth once daily for 2 weeks

Interventions

Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

Aspirin 81 mg

Primary outcome measure

  • Change in mean fluorescence intensity of PAC-1 [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Sandy Byers, RN

402-280-4961sandrabyers@creighton.edu

Caroline Nubel, BS

402-280-4032carolinenubel@creighton.edu

Locations

Creighton University

Recruiting

Omaha, Nebraska, United States, 68178

Contacts

Sandy Byers, RN

402-280-4961sandrabyers@creighton.edu

Principal Investigator:

Khalid Bashir, MD

More Information

Sponsor

Creighton University

Last update posted

Dec 14, 2015

Last verified

Dec, 2015

Keywords

  • Hypertension
  • Platelet activation
  • Platelet aggregation
  • Chlorthalidone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Creighton University on 2015-12-14.