A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

Summary

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Timeline

Start

2005-09-01

Primary completion

2008-01-01

Completion

2008-01-01

Outcome

Missed primary endpoint

registry analysis (unspecified test); Losartan +/- Hydrochlorothiazide; p = 0.999; Mean Difference (Final Values) 0.02 (95% CI -0.02 to 0.06); t-test, 1 sided NCT00546052 ↗

registry analysis (unspecified test); Losartan +/- Hydrochlorothiazide; p = 0.999; Mean Difference (Final Values) 0.04 (95% CI 0.01 to 0.07); t-test, 1 sided NCT00546052 ↗

paper During the 52-week treatment period of the study, FBG and HbA1c did not change significantly. PMID 20147971 ↗

Publications

• Results Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrochlorothiazide	Unknown	12.5 mg	—
Subject	Hydrochlorothiazide	Unknown	25 mg	—
Subject	Losartan	Other / unclassified	50 mg	—
Subject	Losartan	Other / unclassified	100 mg	—

Indications