A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels (TNT)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00327691
First received: May 16, 2006
Last updated: May 1, 2007
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Cerebrovascular Accident Coronary Heart Disease |
Drug: Atorvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary outcome is the time to occurrence of a major
- cardiovascular event, defined as the composite outcome of the
- following clinical endpoints
- CHD death
- Non-fatal/Non-procedure related MI
- Resuscitated cardiac arrest or fatal/non-fatal stroke
Secondary Outcome Measures:
- The occurrence of the following clinical events
- Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
- any coronary event (major coronary event or CABG
- PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
- cerebrovascular event (fatal or non fatal stroke, TIA)
- peripheral vascular disease; hospitalization with primary diagnosis' of CHF
- any cardiovascular event (any of the above); and all-cause mortality.
| Estimated Enrollment: | 8600 |
| Study Start Date: | April 1998 |
| Estimated Study Completion Date: | August 2004 |
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Men and women age 35-75 who have evident CHD
Exclusion Criteria:
Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327691
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Alabaster, Alabama, United States, 35007 | |
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| Birmingham, Alabama, United States, 35294-2041 | |
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| Birmingham, Alabama, United States, 35213 | |
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| Birmingham, Alabama, United States, 35205-4785 | |
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| Hoover, Alabama, United States, 35216 | |
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| Montgomery, Alabama, United States, 36117 | |
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| Mesa, Arizona, United States, 85202 | |
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| Mesa, Arizona, United States, 85206 | |
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| Burbank, California, United States, 91505 | |
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| Camp Pendleton, California, United States, 92055 | |
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| Fresno, California, United States, 93703 | |
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| La Jolla, California, United States, 92037 | |
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| Loma Linda, California, United States, 92354 | |
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| Los Angeles, California, United States, 90048 | |
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| Los Angeles, California, United States, 90017-2395 | |
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| Modesto, California, United States, 95350 | |
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| Hawthorne, New York, United States, 10535 | |
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| Rochester, New York, United States, 14621 | |
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| Syracuse, New York, United States, 13202 | |
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| Oklahoma City, Oklahoma, United States, 73104 | |
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| Allentown, Pennsylvania, United States, 18106-0880 | |
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| Lansdale, Pennsylvania, United States, 19446 | |
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| Pittsburgh, Pennsylvania, United States, 15213 | |
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| Sellersville, Pennsylvania, United States, 18960 | |
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| Pawtucket, Rhode Island, United States, 02860 | |
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| Providence, Rhode Island, United States, 02906 | |
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| Charleston, South Carolina, United States, 29403 | |
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| Sioux Falls, South Dakota, United States, 57105 | |
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| Memphis, Tennessee, United States, 38105 | |
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| Memphis, Tennessee, United States, 38119-5209 | |
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| Memphis, Tennessee, United States, 38104 | |
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| Memphis, Tennessee, United States, 38128 | |
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| Nashville, Tennessee, United States, 37232-6300 | |
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| Houston, Texas, United States, 77030 | |
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| Adelaide, South Australia, Australia, 5000 | |
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| Bedford Park, South Australia, Australia, 5042 | |
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| Hobart, Tasmania, Australia, 7000 | |
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| Nedlands, Western Australia, Australia, 6009 | |
| Austria | |
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| Feldkirch, Austria, A-6807 | |
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| Aalst, Belgium, 9300 | |
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| Johannesburg, Gauteng, South Africa, 2193 | |
| Pfizer Investigational Site | |
| Sunninghill, Gauteng, South Africa, 2157 | |
| Pfizer Investigational Site | |
| Bloemfontein, South Africa, 9301 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7405 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7500 | |
| Pfizer Investigational Site | |
| Parow, South Africa, 7505 | |
| Spain | |
| Pfizer Investigational Site | |
| Unknown, Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Cordoba, Spain, 14004 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28029 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28041 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| San Sebastian, Spain, 20014 | |
| Pfizer Investigational Site | |
| Santiago de Compostela, Spain, 15706 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41013 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41009 | |
| Pfizer Investigational Site | |
| Valladolid, Spain, 47011 | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Bern, Switzerland, 3010 | |
| Pfizer Investigational Site | |
| Geneve 14, Switzerland, CH-1211 | |
| Pfizer Investigational Site | |
| Lausanne, Switzerland, CH-1011 | |
| Pfizer Investigational Site | |
| Lugano, Switzerland, 6900 | |
| Pfizer Investigational Site | |
| St Gallen, Switzerland, CH-9007 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Romford, Essex, United Kingdom, RM7 OBE | |
| Pfizer Investigational Site | |
| London, Greater London, United Kingdom, NW10 7NS | |
| Pfizer Investigational Site | |
| London, Greater London, United Kingdom, SW17 0RE | |
| Pfizer Investigational Site | |
| London, Greater London, United Kingdom, E2 9JX | |
| Pfizer Investigational Site | |
| Aldershot, Hampshire, United Kingdom, GU11 3RB | |
| Pfizer Investigational Site | |
| Farnborough, Kent, United Kingdom, BR6 7AR | |
| Pfizer Investigational Site | |
| Blackpool, Lancashire, United Kingdom, FY3 8NR | |
| Pfizer Investigational Site | |
| Leicester, Leicestershire, United Kingdom, LE3 9QP | |
| Pfizer Investigational Site | |
| London, Middlesex, United Kingdom, HA8 0AD | |
| Pfizer Investigational Site | |
| Coventry, West Midlands, United Kingdom, CV1 4FH | |
| Pfizer Investigational Site | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| Pfizer Investigational Site | |
| Swindon, Wiltshire, United Kingdom, SN3 6BB | |
| Pfizer Investigational Site | |
| Barnet, United Kingdom, EN5 3DJ | |
| Pfizer Investigational Site | |
| Glasgow, United Kingdom, G11 6NT | |
| Pfizer Investigational Site | |
| London, United Kingdom, E1 1BB | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2PF | |
| Pfizer Investigational Site | |
| Paisley, United Kingdom, P1 1HR | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00327691 History of Changes |
| Other Study ID Numbers: | 0981-117, A2581136 |
| Study First Received: | May 16, 2006 |
| Last Updated: | May 1, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Major cardiovascular event Major Coronary event Revascularization |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cerebral Infarction Stroke Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013