Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Creighton University

Status and phase: Withdrawn; Phase 4

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Hydrochlorothiazide 25 mg; Drug: Chlorthalidone 12.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01822860

13-16628

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Treatment:

Drug: Placebo

Chlorthalidone 12.5 mg

Experimental group

Description:

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Treatment:

Drug: Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

Active Comparator group

Description:

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Treatment:

Drug: Hydrochlorothiazide 25 mg