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Chlorthalidone and HCTZ Impacts on Platelet Activation

Information source: Creighton University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Chlorthalidone 12.5 mg (Drug); Hydrochlorothiazide 25 mg (Drug); Aspirin 81 mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Creighton University

Official(s) and/or principal investigator(s):
Khalid Bashir, MD, Principal Investigator, Affiliation: Creighton University

Overall contact:
Tammy L Burns, PharmD, Phone: 402-717-0717, Email: tammyburns@creighton.edu

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.

Clinical Details

Official title: Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in mean fluorescence intensity of PAC-1

Secondary outcome:

Change in CD62P expression

Change in platelet aggregation

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Tammy L Burns, PharmD, Phone: 402-717-0717, Email: tammyburns@creighton.edu

Creighton University, Omaha, Nebraska 68178, United States; Recruiting
Tammy L Burns, PharmD, BCPS, Phone: 402-717-0717, Email: tammyburns@creighton.edu
Tammy L Burns, PharmD, BCPS, Sub-Investigator
Khalid Bashir, MD, Principal Investigator
Michael White, MD, Sub-Investigator
Daniel E Hilleman, PharmD, Sub-Investigator
Venkata M Alla, MD, Sub-Investigator
Venkata Andukuri, MD, Sub-Investigator
Additional Information

Starting date: March 2014
Last updated: October 30, 2014

Page last updated: August 23, 2015

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