Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Phase 4

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Chlorthalidone 12.5 mg; Drug: Hydrochlorothiazide 25 mg

• Registration Number: NCT01822860
• Lead Sponsor: Creighton University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.
Chlorthalidone 12.5 mg	Chlorthalidone 12.5 mg	Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.
Hydrochlorothiazide 25 mg	Hydrochlorothiazide 25 mg	Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Primary Outcome Measures

Name	Time	Method
Flow mediated vasodilatation	4 weeks	Flow mediated vasodilatation will be measured after one month on each drug and placebo

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States