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

NCT00496834 | Completed Phase 4 Results

• 2 other identifiers: 0954-3302007_015
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 24 Weeks

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Losartan or Losartan/HCTZ

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

2

ACTIVE COMPARATOR

Carvedilol or Carvedilol/HCTZ

Drug: Comparator: carvedilol; Drug: Comparator: carvedilol (+) hydrochlorothiazide

Interventions

losartan potassium DRUG

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)

1

Comparator: carvedilol DRUG

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)

2

Comparator: losartan (+) hydrochlorothiazide (HCTZ) DRUG

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)

1

Comparator: carvedilol (+) hydrochlorothiazide DRUG

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)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 22, 2024
• Results First Posted: December 15, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share