Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH

Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00607633

Acronym

CandLE

Enrollment

686

Registered

2008-02-06

Start date

2007-01-31

Completion date

2007-10-31

Last updated

2008-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension, Left Ventricular Hypertrophy

Keywords

essential hypertension, ARB, left ventricular hypertrophy, candesartan

Brief summary

The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Healthy volunteers

Inclusion criteria

* essential hypertension * left ventricular hypertrophy * under candesartan treatment

Design outcomes

Primary

Measure	Time frame
to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index.	app. 3 monthly

Secondary

Measure	Time frame
to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT	app. 3 monthly
to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions.	app. 3 monthly

Outcome results