Chlorthalidone and HCTZ Impacts on Platelet Activation

December 10, 2015 updated by: Creighton University

Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Recruiting
        • Creighton University
        • Contact:
        • Sub-Investigator:
          • Tammy L Burns, PharmD, BCPS
        • Principal Investigator:
          • Khalid Bashir, MD
        • Sub-Investigator:
          • Michael White, MD
        • Sub-Investigator:
          • Daniel E Hilleman, PharmD
        • Sub-Investigator:
          • Venkata M Alla, MD
        • Sub-Investigator:
          • Venkata Andukuri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorthalidone 12.5 mg
Chlorthalidone 12.5 mg by mouth once daily for 2 weeks
Drug: Chlorthalidone 12.5 mg
Experimental: Hydrochlorothiazide 25 mg
Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks
Drug: Hydrochlorothiazide 25 mg
Active Comparator: Aspirin 81 mg
Aspirin 81 mg by mouth once daily for 2 weeks
Drug: Aspirin 81 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean fluorescence intensity of PAC-1
Time Frame: 2 weeks
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CD62P expression
Time Frame: 2 weeks
Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.
2 weeks
Change in platelet aggregation
Time Frame: 2 weeks
Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

Dialysis Clinic, Inc.

Investigators

  • Principal Investigator: Khalid Bashir, MD, Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-16785

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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