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

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: February 6, 2015
Last verified: February 2015
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 
Overall Participants Analyzed 
[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 
[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.

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 


  Outcome Measures
  Show All Outcome Measures

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
No text entered.


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: February 6, 2015
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs