Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090259
First received: August 25, 2004
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: June 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Drug: Losartan 50 mg
Drug: Losartan 150 mg

  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
First patient in: Nov-2001. Last patient out: May-2009. 255 sites in 30 countries participated (Peru , Chile, Columbia, Mexico, Brazil, Belgium, Croatia, France, Germany, Greece, Holland, Italy, Norway, Poland, Russia, Slovenia, Spain, Turkey, UK, Egypt, Lebanon, Morocco, S. Africa, China, Hong Kong, Korea, Malaysia, Philippines, Singapore, Taiwan)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who were on a Angiotensin II Antagonist (AIIA) had the option to begin losartan treatment with open-label losartan 12.5 mg for one week followed by losartan 25 mg for one week and were subsequently randomized to losartan 50 mg or losartan 150 mg.

Reporting Groups
  Description
Losartan 50 mg No text entered.
Losartan 150 mg No text entered.

Participant Flow:   Overall Study
    Losartan 50 mg     Losartan 150 mg  
STARTED     1913     1921  
COMPLETED     1851 [1]   1873 [2]
NOT COMPLETED     62     48  
Lost to Follow-up                 30                 26  
Withdrawal by Subject                 21                 15  
Investigator site closed                 11                 7  
[1] Completed follow-up: 963 on drug, 223 off drug, & 665 at death (death was considered an endpoint)
[2] Completed follow-up: 1005 on drug, 233 off drug,& 635 at death (death was considered an endpoint)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Losartan 50 mg No text entered.
Losartan 150 mg No text entered.
Total Total of all reporting groups

Baseline Measures
    Losartan 50 mg     Losartan 150 mg     Total  
Number of Participants  
[units: participants]
  1913     1921     3834  
Age  
[units: years]
Mean ( Full Range )
  64.1  
  ( 19 to 95 )  
  64.4  
  ( 18 to 98 )  
  64.2  
  ( 18 to 98 )  
Age, Customized  
[units: participants]
     
< 65 years of Age     889     879     1768  
>=65 years of Age     1024     1042     2066  
Gender  
[units: participants]
     
Female     560     583     1143  
Male     1353     1338     2691  
Angiotensin II antagonists  
[units: Participants]
     
No     456     438     894  
Yes     1457     1483     2940  
New York Heart Association (NYHA) functional status [1]
[units: Participants]
     
I No symptoms     2     1     3  
II Mild symptoms     1330     1327     2657  
III Marked limitation     569     583     1152  
IV Severe limitations     12     10     22  
Region  
[units: participants]
     
Asia and Pacific Region     391     390     781  
East Europe     212     207     419  
Middle East and Africa     97     97     194  
Latin America     309     315     624  
West Europe     904     912     1816  
β – Blocker therapy  
[units: Participants]
     
No     543     533     1076  
Yes     1370     1388     2758  
[1]

NYHA Class Symptoms

I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.

IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.




  Outcome Measures
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1.  Primary:   Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure   [ Time Frame: Entire follow-up (median = 4.7 years) ]

2.  Secondary:   Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization   [ Time Frame: Entire follow-up (median = 4.7 years) ]

3.  Secondary:   Number of Participants That Died (Any Cause)   [ Time Frame: Entire follow-up (median = 4.7 years) ]

4.  Secondary:   Number of Participants That Were Hospitalized for Heart Failure   [ Time Frame: Entire follow-up (median = 4.7 years) ]

5.  Secondary:   Number of Participants That Experienced Cardiovascular Hospitalization   [ Time Frame: Entire follow-up (median = 4.7 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090259     History of Changes
Other Study ID Numbers: 0954-948, 2004_004
Study First Received: August 25, 2004
Results First Received: June 30, 2010
Last Updated: October 25, 2013
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs