Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00327691
Registration number
NCT00327691
Ethics application status
Date submitted
16/05/2006
Date registered
18/05/2006
Date last updated
3/05/2007
Titles & IDs
Public title
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
Query!
Scientific title
The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
Query!
Secondary ID [1]
0
0
A2581136
Query!
Secondary ID [2]
0
0
0981-117
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TNT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
0
0
Query!
Cerebrovascular Accident
0
0
Query!
Coronary Heart Disease
0
0
Query!
Condition category
Condition code
Stroke
0
0
0
0
Query!
Haemorrhagic
Query!
Stroke
0
0
0
0
Query!
Ischaemic
Query!
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin
Treatment: Drugs: Atorvastatin
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The primary outcome is the time to occurrence of a major
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Primary outcome [2]
0
0
cardiovascular event, defined as the composite outcome of the
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Query!
Primary outcome [3]
0
0
following clinical endpoints
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Query!
Primary outcome [4]
0
0
CHD death
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Query!
Primary outcome [5]
0
0
Non-fatal/Non-procedure related MI
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Query!
Primary outcome [6]
0
0
Resuscitated cardiac arrest or fatal/non-fatal stroke
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Query!
Secondary outcome [1]
0
0
The occurrence of the following clinical events
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Secondary outcome [2]
0
0
Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Query!
Secondary outcome [3]
0
0
any coronary event (major coronary event or CABG
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Query!
Secondary outcome [4]
0
0
PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Query!
Secondary outcome [5]
0
0
cerebrovascular event (fatal or non fatal stroke, TIA)
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Query!
Secondary outcome [6]
0
0
peripheral vascular disease; hospitalization with primary diagnosis' of CHF
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Query!
Secondary outcome [7]
0
0
any cardiovascular event (any of the above); and all-cause mortality.
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Query!
Eligibility
Key inclusion criteria
Men and women age 35-75 who have evident CHD
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary
hyperlipidemia
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/1998
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - St. Leonards
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Auchenflower
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Brisbane
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Chermside
Query!
Recruitment hospital [5]
0
0
Pfizer Investigational Site - Greenslopes
Query!
Recruitment hospital [6]
0
0
Pfizer Investigational Site - Herston
Query!
Recruitment hospital [7]
0
0
Pfizer Investigational Site - Milton
Query!
Recruitment hospital [8]
0
0
Pfizer Investigational Site - Adelaide
Query!
Recruitment hospital [9]
0
0
Pfizer Investigational Site - Bedford Park
Query!
Recruitment hospital [10]
0
0
Pfizer Investigational Site - Hobart
Query!
Recruitment hospital [11]
0
0
Pfizer Investigational Site - Clayton
Query!
Recruitment hospital [12]
0
0
Pfizer Investigational Site - Parkville
Query!
Recruitment hospital [13]
0
0
Pfizer Investigational Site - Prahran
Query!
Recruitment hospital [14]
0
0
Pfizer Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [3]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [5]
0
0
4130 - Greenslopes
Query!
Recruitment postcode(s) [6]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [7]
0
0
4064 - Milton
Query!
Recruitment postcode(s) [8]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [9]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [10]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [11]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [12]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [13]
0
0
3181 - Prahran
Query!
Recruitment postcode(s) [14]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Delaware
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
District of Columbia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Iowa
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kansas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kentucky
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Louisiana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maine
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maryland
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Massachusetts
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Michigan
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Minnesota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Missouri
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nebraska
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Hampshire
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New Jersey
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New York
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
North Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Ohio
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oklahoma
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Oregon
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Pennsylvania
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Rhode Island
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
South Carolina
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Dakota
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Tennessee
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Texas
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Utah
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Vermont
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Virginia
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Washington
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Wisconsin
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Feldkirch
Query!
Country [42]
0
0
Austria
Query!
State/province [42]
0
0
Oberpullendorf
Query!
Country [43]
0
0
Austria
Query!
State/province [43]
0
0
Wien
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Aalst
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Antwerpen
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Genk
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Godinne
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Leuven
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Lommel
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Neerpelt
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Alberta
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
British Columbia
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Manitoba
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Newfoundland and Labrador
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Nova Scotia
Query!
Country [56]
0
0
Canada
Query!
State/province [56]
0
0
Ontario
Query!
Country [57]
0
0
Canada
Query!
State/province [57]
0
0
Quebec
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Cedex
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Agen
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Bordeaux
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Brest
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Clermont-ferrand
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Lyon
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Marseille
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Paris CEDEX 05
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Rennes
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Roubaix Cdx
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Strasbourg
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Toulouse
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Berlin
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Essen
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Hamburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Schwerte
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Tostedt
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Wurzburg
Query!
Country [76]
0
0
Ireland
Query!
State/province [76]
0
0
Cork
Query!
Country [77]
0
0
Ireland
Query!
State/province [77]
0
0
Dublin
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Bologna
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Cuneo
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Firenze
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Napoli
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Rome
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Udine
Query!
Country [84]
0
0
Netherlands
Query!
State/province [84]
0
0
's-Hertogenbosch
Query!
Country [85]
0
0
Netherlands
Query!
State/province [85]
0
0
Alkmaar
Query!
Country [86]
0
0
Netherlands
Query!
State/province [86]
0
0
Amersfoort
Query!
Country [87]
0
0
Netherlands
Query!
State/province [87]
0
0
Amsterdam
Query!
Country [88]
0
0
Netherlands
Query!
State/province [88]
0
0
Breda
Query!
Country [89]
0
0
Netherlands
Query!
State/province [89]
0
0
Eindhoven
Query!
Country [90]
0
0
Netherlands
Query!
State/province [90]
0
0
Enschede
Query!
Country [91]
0
0
Netherlands
Query!
State/province [91]
0
0
Groningen
Query!
Country [92]
0
0
Netherlands
Query!
State/province [92]
0
0
Leiden
Query!
Country [93]
0
0
Netherlands
Query!
State/province [93]
0
0
Nieuwegein
Query!
Country [94]
0
0
Netherlands
Query!
State/province [94]
0
0
Nijmegen
Query!
Country [95]
0
0
Netherlands
Query!
State/province [95]
0
0
Zwolle
Query!
Country [96]
0
0
South Africa
Query!
State/province [96]
0
0
Gauteng
Query!
Country [97]
0
0
South Africa
Query!
State/province [97]
0
0
Bloemfontein
Query!
Country [98]
0
0
South Africa
Query!
State/province [98]
0
0
Cape Town
Query!
Country [99]
0
0
South Africa
Query!
State/province [99]
0
0
Parow
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Barcelona
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Cordoba
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Madrid
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
San Sebastian
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Santiago de Compostela
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Sevilla
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Valladolid
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Zaragoza
Query!
Country [108]
0
0
Switzerland
Query!
State/province [108]
0
0
Bern
Query!
Country [109]
0
0
Switzerland
Query!
State/province [109]
0
0
Geneve 14
Query!
Country [110]
0
0
Switzerland
Query!
State/province [110]
0
0
Lausanne
Query!
Country [111]
0
0
Switzerland
Query!
State/province [111]
0
0
Lugano
Query!
Country [112]
0
0
Switzerland
Query!
State/province [112]
0
0
St Gallen
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Essex
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Greater London
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Hampshire
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Kent
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Lancashire
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
Leicestershire
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Middlesex
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
West Midlands
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Wiltshire
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Barnet
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Glasgow
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
London
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
Paisley
Query!
Country [126]
0
0
Query!
State/province [126]
0
0
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to determine the degree of additional reduction in
cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently
accepted minimum target level for patients with pre-existing CHD. Secondary objectives
include the safety profile of this treatment strategy, its cost-effectiveness, effect on
other atherosclerotic-related events and procedures, and total mortality.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00327691
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00327691
Download to PDF