COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607633
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 6, 2008
Sponsor:
Information provided by:
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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..

Condition or disease
Essential Hypertension Left Ventricular Hypertrophy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 686 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy
Study Start Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1
Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ambulant patient
Criteria

Inclusion Criteria:

  • essential hypertension
  • left ventricular hypertrophy
  • under candesartan treatment

Exclusion Criteria:

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607633


Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: F. Sonntag, MD Cardiologist, Henstedt-Ulzburg
Study Chair: Andrea Pahor, MD MED Dep., AstraZeneca Germany
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Andrea Pahor, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00607633    
Other Study ID Numbers: NIS-CGE-ATA-2007/2
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: February 6, 2008
Last Verified: January 2008
Keywords provided by AstraZeneca:
essential hypertension
ARB
left ventricular hypertrophy
candesartan
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Essential Hypertension
Hypertrophy, Left Ventricular
Hypertrophy
Vascular Diseases
 Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases