A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
EMPHASIS-HF
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
1 other identifier
interventional
2,743
29 countries
307
Brief Summary
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population. On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Mar 2006
Longer than P75 for phase_3 heart-failure
307 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedResults Posted
Study results publicly available
June 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 22, 2020
December 1, 2020
4.2 years
September 30, 2005
May 20, 2011
December 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)
Secondary Outcomes (16)
Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
- +11 more secondary outcomes
Study Arms (1)
Eplerenone arm
ACTIVE COMPARATOREplerenone administered on top of background standard heart failure therapy
Interventions
Eplerenone administered on top of background standard heart failure therapy
Eligibility Criteria
You may qualify if:
- History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated for fluid overload. Should have participated in the double-blind phase of the EMPHASIS-HF trial
You may not qualify if:
- Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (307)
Pfizer Investigational Site
Phoenix, Arizona, 85008, United States
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Loma Linda, California, 92354, United States
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Merced, California, 95340, United States
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Stockton, California, 95204, United States
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Colorado Springs, Colorado, 80909, United States
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Bridgeport, Connecticut, 06606, United States
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Hartford, Connecticut, 06102, United States
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Washington D.C., District of Columbia, 20037, United States
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Daytona Beach, Florida, 32117, United States
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Gainesville, Florida, 32608, United States
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Jupiter, Florida, 33458, United States
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Melbourne, Florida, 32901, United States
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Rockford, Illinois, 61107, United States
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Indianapolis, Indiana, 46237, United States
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Indianapolis, Indiana, 46260, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40205-3374, United States
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Louisville, Kentucky, 40216, United States
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Baton Rouge, Louisiana, 70808, United States
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Bangor, Maine, 04401, United States
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Annapolis, Maryland, 21401, United States
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Columbia, Maryland, 21044-2914, United States
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Boston, Massachusetts, 02118, United States
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Minneapolis, Minnesota, 55417, United States
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MN, Minnesota, 55101, United States
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Tupelo, Mississippi, 38801-4600, United States
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Tupelo, Mississippi, 38801, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68122, United States
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Omaha, Nebraska, 68131, United States
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Manchester, New Hampshire, 03102, United States
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Albany, New York, 12208, United States
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Rochester, New York, 14618, United States
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Rochester, New York, 14642, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Oklahoma City, Oklahoma, 73104, United States
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Oklahoma City, Oklahoma, 73112, United States
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Beaver, Pennsylvania, 15009, United States
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Doylestown, Pennsylvania, 18901, United States
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Leetsdale, Pennsylvania, 15056, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Cumberland, Rhode Island, 02864, United States
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Germantown, Tennessee, 38138, United States
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Knoxville, Tennessee, 37917, United States
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Dallas, Texas, 75231-7906, United States
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Dallas, Texas, 75231, United States
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Plano, Texas, 75024, United States
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Spokane, Washington, 99204, United States
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Madison, Wisconsin, 53792, United States
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Morón, Pcia. de Buenos Aires, 1708, Argentina
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Buenos Aires, 1428, Argentina
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Córdoba, X5003DCE, Argentina
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Concord, New South Wales, 2139, Australia
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Brisbane, Queensland, 4029, Australia
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Launceston, Tasmania, 7250, Australia
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Antwerp, B-2020, Belgium
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Bonheiden, B-2820, Belgium
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Eupen, B-4700, Belgium
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Genk, 3600, Belgium
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Hasselt, 3500, Belgium
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Huy, B-4500, Belgium
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La Louvière, 7100, Belgium
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Lanaken, 3620, Belgium
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Leuven, 3000, Belgium
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Overpelt, B-3900, Belgium
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Yvoir, 5530, Belgium
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Hamilton, Ontario, L8L 2X2, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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London, Ontario, N6A 5A5, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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St-georges (Beauce), Quebec, G5Y 4T8, Canada
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Brno, 625 00, Czechia
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Brno, 656 91, Czechia
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Hradec Králové, 500 05, Czechia
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Ostrava, 708 52, Czechia
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Pilsen, 30599, Czechia
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Pilsen, 323 00, Czechia
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Prague, 100 34, Czechia
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Prague, 110 00, Czechia
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Prague, 118 33, Czechia
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Prague, 128 08, Czechia
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Prague, 169 02, Czechia
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Příbram, 261 01, Czechia
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Toulouse, Cedex 4, 31403, France
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Créteil, Cedex, 94010, France
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Gap, Cedex, 05000, France
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Angers, 49033, France
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Brest, 29200, France
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Cergy-Pontoise, 95303, France
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Châteauroux, 36019, France
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Gap, 05007, France
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Nantes, 44093, France
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Nice, 06002, France
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Nîmes, 30000, France
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Paris, 75651, France
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Saint-Amand-Montrond, 18206, France
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Strasbourg, 67091, France
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Strasbourg, 67098, France
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Valenciennes, 59300, France
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Bad Nauheim, 61231, Germany
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Bad Rothenfelde, 49214, Germany
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Berlin, 10367, Germany
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Berlin, 12621, Germany
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Berlin, 12683, Germany
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Berlin, 13125, Germany
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Cologne, 50924, Germany
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Dortmund, 44137, Germany
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Duisburg, 47137, Germany
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Essen, 45122, Germany
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Frankfurt am Main, 60594, Germany
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Göttingen, 37075, Germany
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Hagen, 58095, Germany
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Halle, 06110, Germany
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Hanover, 30625, Germany
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Homburg/Saar, 66424, Germany
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Leipzig, 04289, Germany
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Ludwigshafen, 67063, Germany
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Lübeck, 23538, Germany
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Athens, Attica, 16672, Greece
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Haidari, Attica, 12462, Greece
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Athens, 10671, Greece
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Athens, 11527, Greece
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Athens, 11528, Greece
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Athens, 14388, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 54642, Greece
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Thessaloniki, 57010, Greece
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Chai Wan, Hong Kong
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Pokfulam, Hong Kong
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Shatin NT, Hong Kong
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Budapest, 1106, Hungary
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Budapest, 1529, Hungary
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Budapest, H-1134, Hungary
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Debrecen, 4012, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Siófok, 8601, Hungary
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Szeged, H-6720, Hungary
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Hyderabad, Andhra Pradesh, 500 001, India
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Hyderabad, Andhra Pradesh, 500 034, India
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Bangalore, Karnataka, 560 034, India
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Bangalore, Karnataka, 560 054, India
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Pune, Maharshtra, 411 004, India
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Ludhiana, Punjab, 141 001, India
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Chennai, Tamil Nadu, 400 037, India
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Coimbatore, Tamil Nadu, 641 014, India
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Lucknow, Uttar Pradesh, 226 014, India
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Cork, Ireland
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Dublin, 4, Ireland
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Dublin, Co., Ireland
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Galway, Ireland
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Bergamo (BG), 24128, Italy
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Catania, 95123, Italy
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Catania, 95124, Italy
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Florence, 50134, Italy
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Mestre - Zelardino (VE), 30164, Italy
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Milan, 20138, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Palermo, 90100, Italy
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Parma, 43100, Italy
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Piacenza, 29100, Italy
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Roma, 00163, Italy
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Sassari, 07100, Italy
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Trieste, 30147, Italy
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Venezia, 30122, Italy
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Aguascalientes, Aguacalientes, 20230, Mexico
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Guadalajara, Jalisco, 44280, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Mexico City, Mexico City, 02720, Mexico
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31238, Mexico
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San Luis Potosí City, 78210, Mexico
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's-Hertogenbosch, 5211 NL, Netherlands
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Alkmaar, 1815 JD, Netherlands
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Apeldoorn, 7314 ET, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Breda, 4818 CK, Netherlands
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Deventer, 7416 SE, Netherlands
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Dordrecht, 3317 NM, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Heerlen, 6419 PC, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Velp, 6883 AZ, Netherlands
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Zwolle, 8011 JW, Netherlands
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Gdansk, 80-952, Poland
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Krakow, 31-501, Poland
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Lodz, 91-347, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 60-834, Poland
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Stalowa Wola, 37-450, Poland
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Szczecin, 71-455, Poland
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Warsaw, 02-097, Poland
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Warsaw, 03-242, Poland
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Warsaw, 04-628, Poland
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Guilhufe - PNF, Penafiel, 4560-162, Portugal
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Almada, 2801-951, Portugal
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Amadora, 2700-276, Portugal
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Coimbra, 3000-075, Portugal
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Linda a Velha, 2799-523, Portugal
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Lisbon, 1499-005, Portugal
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Lisbon, 1769-001, Portugal
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Oliveira de Azeméis, 3720-275, Portugal
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Portalegre, 7301-853, Portugal
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Porto, 4200-319, Portugal
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Vila Franca de Xira, 2600-178, Portugal
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Vila Real, 5000, Portugal
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Moscow, 113093, Russia
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Moscow, 121552, Russia
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Novosibirsk, 630089, Russia
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S-Petersburg, 192104, Russia
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S-Petersburg, 197022, Russia
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Saint Petersburg, 195257, Russia
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Saint Petersburg, 196084, Russia
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Voronezh, 394053, Russia
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Yaroslavl, 150030, Russia
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Singapore, 168752, Singapore
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Singapore, 308433, Singapore
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Bratislava, 811 05, Slovakia
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Bratislava, 813 69, Slovakia
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Bratislava, 831 03, Slovakia
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Bratislava, 833 03, Slovakia
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Bratislava, 833 48, Slovakia
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Levice, 934 01, Slovakia
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Liptovský Mikuláš, 031 01, Slovakia
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Nitra, 949 01, Slovakia
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Trenčín, 911 01, Slovakia
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Soweto, Johannesburg, 2013, South Africa
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Bloemfontein, 9300, South Africa
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Cape Town, 7405, South Africa
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Cape Town, 7500, South Africa
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Johannesburg, 2013, South Africa
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KwaKhangela, 4013, South Africa
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Kwazulu Natal, 4001, South Africa
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Republic of Korea, Korea, 120-752, South Korea
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Suwon, 443-721, South Korea
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Taegu, 700-721, South Korea
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Santiago de Compostela, LA Coruña, 15706, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Almería, 04009, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Málaga, 29010, Spain
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Ängelholm, 262 81, Sweden
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Bollnäs, 821 34, Sweden
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Falun, 791 82, Sweden
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Gothenburg, 413 45, Sweden
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Gothenburg, 416 85, Sweden
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Gothenburg, SE-416 85, Sweden
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Halmstad, 301 85, Sweden
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Hässleholm, 281 31, Sweden
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Lindesberg, 711 82, Sweden
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Linköping, 58185, Sweden
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Luleå, 971 80, Sweden
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Mölndal, 431 80, Sweden
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Skellefteå, S-931 86, Sweden
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Varberg, 432 41, Sweden
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Vaxjo, 351 85, Sweden
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Simferopol, Autonomous Republic of Crimea, 95026, Ukraine
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Dnipropetrovsk, 49005, Ukraine
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Dnipropetrovsk, 49023, Ukraine
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Dnipropetrovsk, 49060, Ukraine
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Donetsk, 83003, Ukraine
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Donetsk, 83114, Ukraine
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Kharkiv, 61000, Ukraine
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Kharkiv, 61002, Ukraine
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Kiev, 03151, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 04050, Ukraine
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Lviv, 79013, Ukraine
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Lviv, 79015, Ukraine
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Odesa, 65009, Ukraine
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Odesa, 65039, Ukraine
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Uzhhorod, 88014, Ukraine
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Zaporizhzhia, 69118, Ukraine
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Dubai, UAE, United Arab Emirates
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Abu Dhabi, United Arab Emirates
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Knutsford, Cheshire, WA16 0BT, United Kingdom
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Macclesfield, Cheshire, SK10 3BL, United Kingdom
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Belfast, Northern Ireland, BT12 6BA, United Kingdom
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Glasgow, Strathclyde, G11 6NT, United Kingdom
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Belfast, BT12 6BA, United Kingdom
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Coventry, CVZ 2DX, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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Glasgow, G12 8TA, United Kingdom
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Harrow, HA1 3UJ, United Kingdom
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Larbert, FK5 4WR, United Kingdom
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Macclesfield, SK10 3BL, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Milton Keynes, MK6 5LD, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Southend-on-Sea, SS0 0RY, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
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Caracas, Distrito Federal, 1061, Venezuela
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Caracas, Miranda, 1060, Venezuela
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Caracas, Miranda, 1061, Venezuela
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PMID: 34129365DERIVEDMartens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WWH, Bohm M, Pitt B, Zannad F, Rossignol P. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial. Clin Res Cardiol. 2022 Apr;111(4):380-392. doi: 10.1007/s00392-021-01853-8. Epub 2021 Apr 23.
PMID: 33893561DERIVEDChung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
PMID: 33107592DERIVEDMonzo L, Ferreira JP, Abreu P, Szumski A, Bohm M, McMurray JJV, Pitt B, Swedberg K, van Veldhuisen DJ, Girerd N, Vincent J, Zannad F, Rossignol P. Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275.
PMID: 31584516DERIVEDStienen S, Ferreira JP, Vincent J, Busselen M, Li B, McMurray JJV, Pitt B, Girerd N, Rossignol P, Zannad F. Estimated Long-Term Survival With Eplerenone. J Am Coll Cardiol. 2019 May 14;73(18):2357-2359. doi: 10.1016/j.jacc.2019.02.043. No abstract available.
PMID: 31072582DERIVEDFerreira JP, Duarte K, McMurray JJV, Pitt B, van Veldhuisen DJ, Vincent J, Ahmad T, Tromp J, Rossignol P, Zannad F. Data-Driven Approach to Identify Subgroups of Heart Failure With Reduced Ejection Fraction Patients With Different Prognoses and Aldosterone Antagonist Response Patterns. Circ Heart Fail. 2018 Jul;11(7):e004926. doi: 10.1161/CIRCHEARTFAILURE.118.004926.
PMID: 29997240DERIVEDRossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2.
PMID: 24297687DERIVEDEschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27.
PMID: 23810881DERIVEDKrum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013 Jul;6(4):711-8. doi: 10.1161/CIRCHEARTFAILURE.112.000173. Epub 2013 Apr 26.
PMID: 23625945DERIVEDRogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5.
PMID: 23042980DERIVEDZannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.
PMID: 21073363DERIVEDZannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.
PMID: 20388647DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
March 1, 2006
Primary Completion
May 1, 2010
Study Completion
January 1, 2012
Last Updated
December 22, 2020
Results First Posted
June 27, 2011
Record last verified: 2020-12