Official Title: “A Randomized, Comparative, Open-Label and Multi-Center Study to Compare the Efficacy of Arterial Stiffness of Losartan Compared to Carvedilol in Patients With the Essential Hypertension”

The primary objective of this study is to evaluate efficacy of arterial stiffness measured by BA-PWB of losartan compared to carvedilol after 24weeks of treatment in patients with the essential hypertension.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: losartan potassium
  • losartan potassium 50mg, 100mg; duration of treatment : 24 Weeks
• Drug: Comparator: carvedilol
  • Carvedilol 12.5g, 25mg duration of treatment: 24 Weeks
• Drug: Comparator: carvedilol (+) hydrochlorothiazide
  • carvedilol (+) hydrochlorothiazide 25mg/12.5mg; 25mg/25m; duration of treatment: 24 Weeks
• Drug: losartan (+) hydrochlorothiazide
  • losartan (+) hydrochlorothiazide 100mg/12.5mg, 100mg/25mg

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Losartan or Losartan/HCTZ or Carvedilol
• Active Comparator: 2
  • 2. Carvedilol/HCTZ

Primary Measures

• Improvement of arterial stiffness
  • Time Frame: 24 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female adults, age 18 and over
• Essential Hypertension with mean SBP >=140mmHg or mean DBP >=90mmHg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0) (mean of blood pressure values measured twice consecutively at least 2 minutes apart)
• Patient understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

• Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study    
• Patient has known or suspected secondary hypertension of any etiology
• Patient has a history of malignant hypertension or current evidence of impending or active malignant hypertension
• Patient has a history of cerebrovascular accident (stroke) or history of transient ischemic attacks or myocardial infarction

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00496834

Study ID Number: 2007_015

ClinicalTrials.gov Identifier: NCT00496834

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