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Chlorthalidone and HCTZ Impacts on Platelet Activation

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ClinicalTrials.gov Identifier: NCT02100462
Recruitment Status : Unknown
Verified December 2015 by Creighton University.
Recruitment status was:  Recruiting
First Posted : April 1, 2014
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Creighton University

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Chlorthalidone 12.5 mg Drug: Hydrochlorothiazide 25 mg Drug: Aspirin 81 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide
Study Start Date : March 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in CD62P expression [ Time Frame: 2 weeks ]
    Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.

  2. Change in platelet aggregation [ Time Frame: 2 weeks ]
    Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100462


Contacts
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Contact: Sandy Byers, RN 402-280-4961 sandrabyers@creighton.edu
Contact: Caroline Nubel, BS 402-280-4032 carolinenubel@creighton.edu

Locations
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United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68178
Contact: Sandy Byers, RN    402-280-4961    sandrabyers@creighton.edu   
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         
Sponsors and Collaborators
Creighton University
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: Khalid Bashir, MD Creighton University

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Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT02100462     History of Changes
Other Study ID Numbers: 13-16785
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Creighton University:
Hypertension
Platelet activation
Platelet aggregation
Chlorthalidone
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Chlorthalidone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antihypertensive Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators