Chlorthalidone and HCTZ Impacts on Platelet Activation

Hypertension Clinical Trial

Official title:

Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02100462
• Other study ID #: 13-16785
• Status: Recruiting
• Phase: Phase 4
• First received: March 27, 2014
• Last updated: December 10, 2015
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: Sandy Byers, RN
• Phone: 402-280-4961
• Email: sandrabyers[@]creighton.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Chlorthalidone 12.5 mg

• Hydrochlorothiazide 25 mg

• Aspirin 81 mg

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean fluorescence intensity of PAC-1	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	No
Secondary	Change in CD62P expression	Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.	2 weeks	No
Secondary	Change in platelet aggregation	Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA	2 weeks	No