LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)

Official Title: “A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients”

The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.

Intervention(s) in this Clinical Trial

• Drug: losartan potassium
  • Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
• Drug: Comparator: carvedilol
  • Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
• Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
  • Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
• Drug: Comparator: carvedilol (+) hydrochlorothiazide
  • Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Losartan or Losartan/HCTZ
• Active Comparator: 2
  • Carvedilol or Carvedilol/HCTZ

Primary Measures

• Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
  • Time Frame: Baseline and 24 Weeks
    Safety Issue?: No
• PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
  • Time Frame: Baseline and 24 Weeks
    Safety Issue?: No

Secondary Measures

• Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
  • Time Frame: Baseline and 24 weeks
    Safety Issue?: No
• Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
  • Time Frame: Baseline and 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or Female adults, 18 years or over
• Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean
• DBP (diastolic blood pressure) ≥ 90 mm Hg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).
• If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)
• Patient who is willing to, and is able to sign the informed consent form

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 history of malignant hypertension
• Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
• Patient takes antihypertensive drugs

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 Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: MK-0954-330

ClinicalTrials.gov Identifier: NCT00496834

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

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site