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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00496834
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2008-02-01
• Primary Completion: 2009-09-01
• Study Completion: 2009-09-01
• Results First Submitted: 2010-08-26
• Results First Submitted QC: 2010-11-18
• Results First Posted: 2010-12-15
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	losartan potassium	Losartan or Losartan/HCTZ

Primary Outcome Measures

Name	Time	Method
Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	Baseline and 24 Weeks	Analysis was performed in the modified intention to treat (mITT) population.
PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	Baseline and 24 Weeks	Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	Baseline and 24 weeks
Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug	Baseline and 24 weeks