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

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ClinicalTrials.gov Identifier: NCT00496834
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : December 15, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: losartan potassium Drug: Comparator: carvedilol Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ) Drug: Comparator: carvedilol (+) hydrochlorothiazide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients
Actual Study Start Date : February 1, 2008
Actual Primary Completion Date : September 1, 2009
Actual Study Completion Date : September 1, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Losartan or Losartan/HCTZ
Drug: losartan potassium
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)
Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
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)
Active Comparator: 2
Carvedilol or Carvedilol/HCTZ
Drug: Comparator: carvedilol
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)
Drug: Comparator: carvedilol (+) hydrochlorothiazide
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)



Primary Outcome Measures :
  1. Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug [ Time Frame: Baseline and 24 Weeks ]
    Analysis was performed in the modified intention to treat (mITT) population.

  2. PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug [ Time Frame: 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 :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496834


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496834     History of Changes
Obsolete Identifiers: NCT01001416
Other Study ID Numbers: 0954-330
2007_015
First Posted: July 4, 2007    Key Record Dates
Results First Posted: December 15, 2010
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Carvedilol
Hydrochlorothiazide
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists