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

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Organon

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: losartan potassium
Drug: Comparator: carvedilol (+) hydrochlorothiazide
Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
Drug: Comparator: carvedilol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496834
0954-330
2007_015

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

201 participants in 2 patient groups

1
Experimental group
Description:
Losartan or Losartan/HCTZ
Treatment:
Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
Drug: losartan potassium
2
Active Comparator group
Description:
Carvedilol or Carvedilol/HCTZ
Treatment:
Drug: Comparator: carvedilol (+) hydrochlorothiazide
Drug: Comparator: carvedilol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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