Official Title: “A Multicenter, Non-Comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy”

The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Candesartan
  • once daily oral tablet
• Drug: Felodipine
• Procedure: Study manual adherence

Primary Measures

• To investigate the percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy treated with candesartan
  • Time Frame: assessed after 24 weeks of therapy
    Safety Issue?: No

Secondary Measures

• LVH regression
  • Time Frame: assessed after 24 weeks of therapy
    Safety Issue?: No
• Change of systolic and diastolic blood pressure
  • Time Frame: assessed at each visit
    Safety Issue?: No
• Percent change of proBNP in patients treated with candesartan only vs candesartan+felodipine
  • Time Frame: assessed after 24 weeks of therapy
    Safety Issue?: No
• Change of mean ambulatory blood pressure
  • Time Frame: assessed after 24 weeks of therapy
    Safety Issue?: No
• Change of collagen markers
  • Time Frame: assessed after 24 weeks of therapy
    Safety Issue?: No

Inclusion Criteria:

• Hypertension with diastolic blood pressure within 95-115mmHg or/and systolic blood pressure within 160-200 mmHg
• Patients diagnosed as left ventricular hypertrophy by electrocardiogram

Exclusion Criteria:

• Secondary hypertension
• History of myocardial infarction
• Stroke within the previous 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

JeeWoong Son, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348686

Study ID Number: D2452L00012

ClinicalTrials.gov Identifier: NCT00348686

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)