Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Hypertension Clinical Trial

Official title:

The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01822860
• Other study ID #: 13-16628
• Status: Withdrawn
• Phase: Phase 4
• First received: March 28, 2013
• Last updated: March 24, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.

Description:

This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 or older

• Diagnosis of hypertension

• Current blood pressure > 120/80 mm Hg

Exclusion Criteria:

• Use of a thiazide-type diuretic within the last 1 month

• Known allergy to any study medications

• History of gout or hyperuricemia

• SCr >/= 1.8 mg/dl or CrCl < 25 ml/min

• Pregnancy or breastfeeding or planning to become pregnant during study period

• Dementia or cognitive impairment

• Hypokalemia

• Acute coronary syndrome or stroke within 6 months

• Current use of sildenafil, tadalafil, or vardenafil

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Chlorthalidone 12.5 mg

• Hydrochlorothiazide 25 mg

• Placebo

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated vasodilatation	Flow mediated vasodilatation will be measured after one month on each drug and placebo	4 weeks	No