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Trial record 1 of 1 for:    sparcl
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Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke (SPARCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147602
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE November 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Time to occurrence of fatal or non-fatal stroke
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2006)
  • Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina.
  • Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
a.Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina. b. Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke
Official Title  ICMJE A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke
Brief Summary To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Drug: atorvastatin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
4732
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previous stroke or TIA

Exclusion Criteria:

  • coronary heart disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147602
Other Study ID Numbers  ICMJE 0981-342
A2581138
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP