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Chlorthalidone and HCTZ Impacts on Platelet Activation

NCT ID: NCT02100462

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension Platelet activation Platelet aggregation Chlorthalidone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Chlorthalidone 12.5 mg

Chlorthalidone 12.5 mg by mouth once daily for 2 weeks

Group Type EXPERIMENTAL

Chlorthalidone 12.5 mg

Intervention Type DRUG

Hydrochlorothiazide 25 mg

Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

Group Type EXPERIMENTAL

Hydrochlorothiazide 25 mg

Intervention Type DRUG

Aspirin 81 mg

Aspirin 81 mg by mouth once daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type DRUG

Interventions

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Chlorthalidone 12.5 mg

Intervention Type DRUG

Hydrochlorothiazide 25 mg

Intervention Type DRUG

Aspirin 81 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dialysis Clinic, Inc.

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khalid Bashir, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sandy Byers, RN

Role: CONTACT

Phone: 402-280-4961

Email: [email protected]

Caroline Nubel, BS

Role: CONTACT

Phone: 402-280-4032

Email: [email protected]

Facility Contacts

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Sandy Byers, RN

Role: primary

References

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Bashir K, Burns T, Pirruccello SJ, Aurit SJ, Hilleman DE. Comparative antiplatelet effects of chlorthalidone and hydrochlorothiazide. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1310-1315. doi: 10.1111/jch.14564. Epub 2022 Sep 6.

Reference Type DERIVED
PMID: 36067089 (View on PubMed)

Other Identifiers

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13-16785

Identifier Type: -

Identifier Source: org_study_id