Phase 4 N=201 Randomized Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00496834 ↗

Enrolled (actual)

201

Serious AEs

5.5%

Results posted

Dec 2010

Primary outcome: Primary: Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug — 0.28; -0.12 meters/second

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: losartan potassium (Drug); Comparator: carvedilol (Drug); Comparator: losartan (+) hydrochlorothiazide (HCTZ) (Drug); Comparator: carvedilol (+) hydrochlorothiazide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	0.28; -0.12	—
PRIMARY PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	0.16; -0.20	—
SECONDARY Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	-15.08; -14.81	0.9032
SECONDARY Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	-8.43; -7.81	0.6574

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00496834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.