Official Title: “Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy”

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..

Study Type: Observational

Study Design: Cohort, Prospective

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT

Primary Measures

• 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.
  • Time Frame: app. 3 monthly
    

Secondary Measures

• to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT
  • Time Frame: 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.
  • Time Frame: app. 3 monthly
    

Inclusion Criteria:

• essential hypertension
• left ventricular hypertrophy
• under candesartan treatment

Exclusion Criteria:

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

F. Sonntag, MD Principal Investigator Cardiologist, Henstedt-Ulzburg  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607633

Study ID Number: NIS-CGE-ATA-2007/2

ClinicalTrials.gov Identifier: NCT00607633

Health Authority: Germany: Federal Institute for Drugs and Medical Devices