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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496834
First received: July 3, 2007
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
Results First Received: August 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium
Drug: Comparator: carvedilol
Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
Drug: Comparator: carvedilol (+) hydrochlorothiazide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
7 centers participated in this study (7 medical centers of university). FPE (First patient enrolled): Feb-2008, FPI (First patient in): Feb-2008, LPO (Last patient out): Sep-2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Losartan Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 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).
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).

Participant Flow:   Overall Study
    Losartan     Carvedilol  
STARTED     101     100  
COMPLETED     83     87  
NOT COMPLETED     18     13  
Withdrawal by Subject                 4                 6  
Contraindicated medication administered                 0                 1  
Inclusion/exclusion criteria not met                 3                 2  
Adverse Event                 5                 3  
IP administration violation                 2                 0  
Lost to Follow-up                 2                 0  
Blood Pressure control failure                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Losartan Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 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).
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).
Total Total of all reporting groups

Baseline Measures
    Losartan     Carvedilol     Total  
Number of Participants  
[units: participants]
 		  101     100     201  
Age  
[units: years]
Mean ± Standard Deviation 		  49.0  ± 9.3     50.1  ± 10.2     49.6  ± 9.7  
Age, Customized  
[units: participants]
 		     
>= 18 to < 65 years     96     91     187  
>=65 years     5     9     14  
Gender  
[units: participants]
 		     
Female     63     57     120  
Male     38     43     81  
DBP (diastolic blood pressure)  
[units: mm Hg]
Mean ± Standard Deviation 		  96.4  ± 8.8     96.4  ± 8.3     96.4  ± 8.5  
Height  
[units: Centimeters]
Mean ± Standard Deviation 		  164.9  ± 7.8     163.3  ± 9.2     164.1  ± 8.5  
PWV (pulse wave velocity)  
[units: meters/second]
Mean ± Standard Deviation 		  7.6  ± 1.4     7.7  ± 1.4     7.6  ± 1.4  
Pulse  
[units: BPM (beats per minute)]
Mean ± Standard Deviation 		  71.8  ± 10.0     72.3  ± 10.0     72.0  ± 10.0  
SBP (systolic blood pressure)  
[units: mm Hg]
Mean ± Standard Deviation 		  150.6  ± 11.0     152.7  ± 12.1     151.6  ± 11.6  
Weight  
[units: Kilograms]
Mean ± Standard Deviation 		  70.9  ± 10.6     69.9  ± 13.2     70.4  ± 12.0  



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Primary:   PWV 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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3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00496834     History of Changes
Obsolete Identifiers: NCT01001416
Other Study ID Numbers: MK-0954-330, 2007_015
Study First Received: July 3, 2007
Results First Received: August 26, 2010
Last Updated: November 18, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)