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

Organon and Co201 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

201

Conditions

Hypertension

Interventions

losartan potassiumDRUG

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)

Comparator: carvedilolDRUG

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)

Comparator: losartan (+) hydrochlorothiazide (HCTZ)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug

Analysis was performed in the modified intention to treat (mITT) population.

Time frame: Baseline and 24 Weeks

PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug

Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.

Time frame: Baseline and 24 Weeks

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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