TNT: A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00327691
Collaborator
(none)
8,600
314
76
27.4
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Apr 1, 1998
Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

  1. The primary outcome is the time to occurrence of a major []

  2. cardiovascular event, defined as the composite outcome of the []

  3. following clinical endpoints []

  4. CHD death []

  5. Non-fatal/Non-procedure related MI []

  6. Resuscitated cardiac arrest or fatal/non-fatal stroke []

Secondary Outcome Measures

  1. The occurrence of the following clinical events []

  2. Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest) []

  3. any coronary event (major coronary event or CABG []

  4. PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina) []

  5. cerebrovascular event (fatal or non fatal stroke, TIA) []

  6. peripheral vascular disease; hospitalization with primary diagnosis' of CHF []

  7. any cardiovascular event (any of the above); and all-cause mortality. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Alabaster Alabama United States 35007
2 Pfizer Investigational Site Birmingham Alabama United States 35205-4785
3 Pfizer Investigational Site Birmingham Alabama United States 35213
4 Pfizer Investigational Site Birmingham Alabama United States 35294-2041
5 Pfizer Investigational Site Hoover Alabama United States 35216
6 Pfizer Investigational Site Montgomery Alabama United States 36117
7 Pfizer Investigational Site Mesa Arizona United States 85202
8 Pfizer Investigational Site Mesa Arizona United States 85206
9 Pfizer Investigational Site Burbank California United States 91505
10 Pfizer Investigational Site Camp Pendleton California United States 92055
11 Pfizer Investigational Site Fresno California United States 93703
12 Pfizer Investigational Site La Jolla California United States 92037
13 Pfizer Investigational Site Loma Linda California United States 92354
14 Pfizer Investigational Site Los Angeles California United States 90017-2395
15 Pfizer Investigational Site Los Angeles California United States 90048
16 Pfizer Investigational Site Modesto California United States 95350
17 Pfizer Investigational Site Pasadena California United States 91105
18 Pfizer Investigational Site Rancho Mirage California United States 92270
19 Pfizer Investigational Site San Diego California United States 92134-3303
20 Pfizer Investigational Site San Francisco California United States 94143-0130
21 Pfizer Investigational Site San Francisco California United States 94143-0326
22 Pfizer Investigational Site Santa Rosa California United States 95403
23 Pfizer Investigational Site Stanford California United States
24 Pfizer Investigational Site Aurora Colorado United States 80012
25 Pfizer Investigational Site Denver Colorado United States 80203
26 Pfizer Investigational Site Denver Colorado United States 80218
27 Pfizer Investigational Site Denver Colorado United States 80220
28 Pfizer Investigational Site Bridgeport Connecticut United States 06610
29 Pfizer Investigational Site Hartford Connecticut United States 06102
30 Pfizer Investigational Site New Britain Connecticut United States 06053
31 Pfizer Investigational Site Newark Delaware United States 19718
32 Pfizer Investigational Site Washington District of Columbia United States 20037
33 Pfizer Investigational Site Clearwater Florida United States 33756
34 Pfizer Investigational Site Gainsville Florida United States 32608
35 Pfizer Investigational Site Gainsville Florida United States 32610
36 Pfizer Investigational Site Hollywood Florida United States 33021
37 Pfizer Investigational Site Inverness Florida United States 34452
38 Pfizer Investigational Site Lakeland Florida United States 33805
39 Pfizer Investigational Site Miami Florida United States 33173
40 Pfizer Investigational Site Miami Florida United States 33176
41 Pfizer Investigational Site Ocala Florida United States 34474
42 Pfizer Investigational Site Orlando Florida United States 32803
43 Pfizer Investigational Site Port Charlotte Florida United States 33952
44 Pfizer Investigational Site Sarasota Florida United States 34239
45 Pfizer Investigational Site Stuart Florida United States 34996
46 Pfizer Investigational Site Tamarac Florida United States 33321
47 Pfizer Investigational Site The Villages Florida United States 32159
48 Pfizer Investigational Site Atlanta Georgia United States 30309
49 Pfizer Investigational Site Canton Georgia United States 30114
50 Pfizer Investigational Site Berwyn Illinois United States 60402
51 Pfizer Investigational Site Blue Island Illinois United States 60406
52 Pfizer Investigational Site Chicago Illinois United States 60610
53 Pfizer Investigational Site Chicago Illinois United States 60611
54 Pfizer Investigational Site DuQuoin Illinois United States 62832
55 Pfizer Investigational Site Evanston Illinois United States 60201
56 Pfizer Investigational Site Lake Forest Illinois United States 60045
57 Pfizer Investigational Site Marion Illinois United States 62959
58 Pfizer Investigational Site Pekin Illinois United States 61554
59 Pfizer Investigational Site Peoria Illinois United States 61603
60 Pfizer Investigational Site Peoria Illinois United States 61614
61 Pfizer Investigational Site Beech Grove Indiana United States 46107
62 Pfizer Investigational Site Evansville Indiana United States 47710
63 Pfizer Investigational Site Fort Wayne Indiana United States 46805
64 Pfizer Investigational Site Fort Wayne Indiana United States 46825
65 Pfizer Investigational Site Jeffersonville Indiana United States 47130
66 Pfizer Investigational Site Scottsburg Indiana United States 47170
67 Pfizer Investigational Site Des Moines Iowa United States 50314
68 Pfizer Investigational Site Iowa City Iowa United States 52242
69 Pfizer Investigational Site Kansas City Kansas United States 66160-7200
70 Pfizer Investigational Site Lathe Kansas United States 66061
71 Pfizer Investigational Site Overland Park Kansas United States 66213
72 Pfizer Investigational Site Wichita Kansas United States 67220
73 Pfizer Investigational Site Edgewood Kentucky United States 41017
74 Pfizer Investigational Site Erlanger Kentucky United States 41018
75 Pfizer Investigational Site Louisville Kentucky United States 40202
76 Pfizer Investigational Site Marrero Louisiana United States 70072
77 Pfizer Investigational Site New Orleans Louisiana United States 70112
78 Pfizer Investigational Site New Orleans Louisiana United States 70121
79 Pfizer Investigational Site Portland Maine United States 04102
80 Pfizer Investigational Site Baltimore Maryland United States 21201
81 Pfizer Investigational Site Baltimore Maryland United States 21204
82 Pfizer Investigational Site Baltimore Maryland United States 21205
83 Pfizer Investigational Site Baltimore Maryland United States 21208
84 Pfizer Investigational Site Baltimore Maryland United States 21218
85 Pfizer Investigational Site Baltimore Maryland United States 21224
86 Pfizer Investigational Site Baltimore Maryland United States 21228
87 Pfizer Investigational Site Baltimore Maryland United States 21229
88 Pfizer Investigational Site Baltimore Maryland United States 21237
89 Pfizer Investigational Site Baltimore Maryland United States 21287
90 Pfizer Investigational Site Bel Air Maryland United States 21014
91 Pfizer Investigational Site Westminster Maryland United States 21157
92 Pfizer Investigational Site Boston Massachusetts United States 02111
93 Pfizer Investigational Site Boston Massachusetts United States 02215
94 Pfizer Investigational Site Burlington Massachusetts United States 1805
95 Pfizer Investigational Site Dearborn Michigan United States 48126
96 Pfizer Investigational Site Detroit Michigan United States 48202
97 Pfizer Investigational Site Farmington Hill Michigan United States 48336
98 Pfizer Investigational Site Sterling Heights Michigan United States 48310
99 Pfizer Investigational Site West Bloomfield Michigan United States 48322
100 Pfizer Investigational Site Duluth Minnesota United States 55805
101 Pfizer Investigational Site Edina Minnesota United States 55435
102 Pfizer Investigational Site Maplewood Minnesota United States 55109
103 Pfizer Investigational Site Minneapolis Minnesota United States 55455
104 Pfizer Investigational Site St. Paul Minnesota United States 55102
105 Pfizer Investigational Site Kansas City Missouri United States 64111
106 Pfizer Investigational Site St. Louis Missouri United States 63104
107 Pfizer Investigational Site St. Louis Missouri United States 63110-0205
108 Pfizer Investigational Site St. Louis Missouri United States 63110
109 Pfizer Investigational Site St. Louis Missouri United States 63117
110 Pfizer Investigational Site St. Louis Missouri United States 63141
111 Pfizer Investigational Site Papillion Nebraska United States 68046
112 Pfizer Investigational Site Manchester New Hampshire United States 03102
113 Pfizer Investigational Site New Brunswick New Jersey United States 08901
114 Pfizer Investigational Site Albany New York United States 12208
115 Pfizer Investigational Site Brooklyn New York United States 11203
116 Pfizer Investigational Site Hawthorne New York United States 10535
117 Pfizer Investigational Site Manlius New York United States 13104
118 Pfizer Investigational Site New York New York United States 10021
119 Pfizer Investigational Site New York New York United States 10029
120 Pfizer Investigational Site New York New York United States 10032
121 Pfizer Investigational Site Rochester New York United States 14607
122 Pfizer Investigational Site Rochester New York United States 14618
123 Pfizer Investigational Site Rochester New York United States 14621
124 Pfizer Investigational Site Syracuse New York United States 13202
125 Pfizer Investigational Site Syracuse New York United States 13210
126 Pfizer Investigational Site Valhalla New York United States 10595
127 Pfizer Investigational Site Asheville North Carolina United States 28803
128 Pfizer Investigational Site Durham North Carolina United States 27710
129 Pfizer Investigational Site Eden North Carolina United States 27288
130 Pfizer Investigational Site Winston-Salem North Carolina United States 27157
131 Pfizer Investigational Site Beachwood Ohio United States 44122
132 Pfizer Investigational Site Cincinnati Ohio United States 45219
133 Pfizer Investigational Site Cincinnati Ohio United States 45229
134 Pfizer Investigational Site Cincinnati Ohio United States 45246
135 Pfizer Investigational Site Cleveland Ohio United States 44106-5038
136 Pfizer Investigational Site Cleveland Ohio United States 44195
137 Pfizer Investigational Site Columbus Ohio United States 43210
138 Pfizer Investigational Site Columbus Ohio United States 43221
139 Pfizer Investigational Site Kettering Ohio United States 45429-1221
140 Pfizer Investigational Site Lorain Ohio United States 44053
141 Pfizer Investigational Site Sandusky Ohio United States 44870
142 Pfizer Investigational Site Oklahoma City Oklahoma United States 73104
143 Pfizer Investigational Site Tulsa Oklahoma United States 74133
144 Pfizer Investigational Site Tulsa Oklahoma United States 74136-1920
145 Pfizer Investigational Site Tulsa Oklahoma United States 74136
146 Pfizer Investigational Site Eugene Oregon United States 97401
147 Pfizer Investigational Site Portland Oregon United States 97210
148 Pfizer Investigational Site Portland Oregon United States 97216
149 Pfizer Investigational Site Allentown Pennsylvania United States 18102
150 Pfizer Investigational Site Allentown Pennsylvania United States 18106-0880
151 Pfizer Investigational Site Lansdale Pennsylvania United States 19446
152 Pfizer Investigational Site Lehighton Pennsylvania United States 18235
153 Pfizer Investigational Site Philadelphia Pennsylvania United States 19104
154 Pfizer Investigational Site Philadelphia Pennsylvania United States 19107
155 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15213
156 Pfizer Investigational Site Sellersville Pennsylvania United States 18960
157 Pfizer Investigational Site Pawtucket Rhode Island United States 02860
158 Pfizer Investigational Site Providence Rhode Island United States 02906
159 Pfizer Investigational Site Charleston South Carolina United States 29403
160 Pfizer Investigational Site Sioux Falls South Dakota United States 57105
161 Pfizer Investigational Site Sioux Falls South Dakota United States 57108
162 Pfizer Investigational Site Memphis Tennessee United States 38104
163 Pfizer Investigational Site Memphis Tennessee United States 38105
164 Pfizer Investigational Site Memphis Tennessee United States 38119-5209
165 Pfizer Investigational Site Memphis Tennessee United States 38128
166 Pfizer Investigational Site Nashville Tennessee United States 37205
167 Pfizer Investigational Site Nashville Tennessee United States 37232-6300
168 Pfizer Investigational Site Austin Texas United States 78756
169 Pfizer Investigational Site Dallas Texas United States 75235
170 Pfizer Investigational Site Dallas Texas United States 75246
171 Pfizer Investigational Site Dallas Texas United States 75390-9047
172 Pfizer Investigational Site Denton Texas United States 76204
173 Pfizer Investigational Site Houston Texas United States 77030
174 Pfizer Investigational Site Lackland AFB Texas United States 78236-5300
175 Pfizer Investigational Site San Antonio Texas United States 78229
176 Pfizer Investigational Site Salt Lake City Utah United States 84124
177 Pfizer Investigational Site Burlington Vermont United States 05401
178 Pfizer Investigational Site Richmond Virginia United States 23249
179 Pfizer Investigational Site Richmond Virginia United States 23298
180 Pfizer Investigational Site Seattle Washington United States 98104
181 Pfizer Investigational Site Milwaukee Wisconsin United States 53295
182 Pfizer Investigational Site St. Leonards New South Wales Australia 2065
183 Pfizer Investigational Site Auchenflower Queensland Australia 4066
184 Pfizer Investigational Site Brisbane Queensland Australia 4029
185 Pfizer Investigational Site Chermside Queensland Australia 4032
186 Pfizer Investigational Site Greenslopes Queensland Australia 4130
187 Pfizer Investigational Site Herston Queensland Australia 4029
188 Pfizer Investigational Site Milton Queensland Australia 4064
189 Pfizer Investigational Site Adelaide South Australia Australia 5000
190 Pfizer Investigational Site Bedford Park South Australia Australia 5042
191 Pfizer Investigational Site Hobart Tasmania Australia 7000
192 Pfizer Investigational Site Clayton Victoria Australia 3168
193 Pfizer Investigational Site Parkville Victoria Australia 3050
194 Pfizer Investigational Site Prahran Victoria Australia 3181
195 Pfizer Investigational Site Nedlands Western Australia Australia 6009
196 Pfizer Investigational Site Feldkirch Austria A-6807
197 Pfizer Investigational Site Oberpullendorf Austria A-7350
198 Pfizer Investigational Site Wien Austria 1100
199 Pfizer Investigational Site Wien Austria A-1090
200 Pfizer Investigational Site Aalst Belgium 9300
201 Pfizer Investigational Site Antwerpen Belgium B-2020
202 Pfizer Investigational Site Genk Belgium 3600
203 Pfizer Investigational Site Genk Belgium B-3600
204 Pfizer Investigational Site Godinne Belgium 5530
205 Pfizer Investigational Site Leuven Belgium 3000
206 Pfizer Investigational Site Lommel Belgium 3920
207 Pfizer Investigational Site Neerpelt Belgium 3910
208 Pfizer Investigational Site Calgary Alberta Canada T2E 7C5
209 Pfizer Investigational Site Calgary Alberta Canada T2N 4N1
210 Pfizer Investigational Site Edmonton Alberta Canada T5R 4H5
211 Pfizer Investigational Site Edmonton Alberta Canada T6G 2B7
212 Pfizer Investigational Site Nanaimo British Columbia Canada V9S 2B8
213 Pfizer Investigational Site Vancouver British Columbia Canada V6R 1Y6
214 Pfizer Investigational Site Victoria British Columbia Canada V8T 5G4
215 Pfizer Investigational Site Winnipeg Manitoba Canada R3A 1R9
216 Pfizer Investigational Site St. John's Newfoundland and Labrador Canada A1B 3V6
217 Pfizer Investigational Site Halifax Nova Scotia Canada B3H 3A7
218 Pfizer Investigational Site Hamilton Ontario Canada L8L 2X2
219 Pfizer Investigational Site London Ontario Canada N6A 4G5
220 Pfizer Investigational Site Ottawa Ontario Canada K1Y 4W7
221 Pfizer Investigational Site Sudbury Ontario Canada P3E 1B8
222 Pfizer Investigational Site Toronto Ontario Canada M5C 2T2
223 Pfizer Investigational Site Chicoutimi Quebec Canada G7H 5H6
224 Pfizer Investigational Site Montreal Quebec Canada H1T 1C8
225 Pfizer Investigational Site Montreal Quebec Canada H2W 1R7
226 Pfizer Investigational Site Montreal Quebec Canada H3A 1A1
227 Pfizer Investigational Site Sherbrooke Quebec Canada J1H 5N4
228 Pfizer Investigational Site St-foy Quebec Canada G1V 4G2
229 Pfizer Investigational Site Quebec Canada G1R 2J6
230 Pfizer Investigational Site Pessac Cedex France 33604
231 Pfizer Investigational Site Agen France 47000
232 Pfizer Investigational Site Bordeaux France 33000
233 Pfizer Investigational Site Brest France 29200
234 Pfizer Investigational Site Clermont-ferrand France 63003
235 Pfizer Investigational Site Lyon France 69003
236 Pfizer Investigational Site Marseille France 13915 Cedex 20
237 Pfizer Investigational Site Paris CEDEX 05 France 75230
238 Pfizer Investigational Site Rennes France 35033
239 Pfizer Investigational Site Roubaix Cdx France 59056
240 Pfizer Investigational Site Strasbourg France 67091
241 Pfizer Investigational Site Toulouse France 31059
242 Pfizer Investigational Site Toulouse France 31400
243 Pfizer Investigational Site Berlin Germany 13353
244 Pfizer Investigational Site Berlin Germany 13439
245 Pfizer Investigational Site Essen Germany 45329
246 Pfizer Investigational Site Hamburg Germany 20246
247 Pfizer Investigational Site Schwerte Germany D-58239
248 Pfizer Investigational Site Tostedt Germany 21255
249 Pfizer Investigational Site Wurzburg Germany 97070
250 Pfizer Investigational Site Cork Ireland
251 Pfizer Investigational Site Dublin Ireland D8
252 Pfizer Investigational Site Bologna Italy 40138
253 Pfizer Investigational Site Bologna Italy 40139
254 Pfizer Investigational Site Cuneo Italy 12100
255 Pfizer Investigational Site Firenze Italy 50134
256 Pfizer Investigational Site Napoli Italy 80131
257 Pfizer Investigational Site Rome Italy 00184
258 Pfizer Investigational Site Udine Italy 33100
259 Pfizer Investigational Site 's-Hertogenbosch Netherlands 5211 NL
260 Pfizer Investigational Site Alkmaar Netherlands 1815 JD
261 Pfizer Investigational Site Amersfoort Netherlands 3818 ES
262 Pfizer Investigational Site Amsterdam Netherlands 1105 AZ
263 Pfizer Investigational Site Breda Netherlands 4818 CK
264 Pfizer Investigational Site Eindhoven Netherlands 5623 EJ
265 Pfizer Investigational Site Enschede Netherlands 7513 ER
266 Pfizer Investigational Site Groningen Netherlands 9713 GZ
267 Pfizer Investigational Site Groningen Netherlands 9728 NZ
268 Pfizer Investigational Site Leiden Netherlands 2333 ZA
269 Pfizer Investigational Site Nieuwegein Netherlands 3435 CM
270 Pfizer Investigational Site Nijmegen Netherlands 6532 SZ
271 Pfizer Investigational Site Zwolle Netherlands 8011 JW
272 Pfizer Investigational Site Zwolle Netherlands 8025 AB
273 Pfizer Investigational Site Johannesburg Gauteng South Africa 2193
274 Pfizer Investigational Site Sunninghill Gauteng South Africa 2157
275 Pfizer Investigational Site Bloemfontein South Africa 9301
276 Pfizer Investigational Site Cape Town South Africa 7405
277 Pfizer Investigational Site Cape Town South Africa 7500
278 Pfizer Investigational Site Parow South Africa 7505
279 Pfizer Investigational Site Barcelona Spain 08035
280 Pfizer Investigational Site Barcelona Spain 08036
281 Pfizer Investigational Site Cordoba Spain 14004
282 Pfizer Investigational Site Madrid Spain 28007
283 Pfizer Investigational Site Madrid Spain 28029
284 Pfizer Investigational Site Madrid Spain 28040
285 Pfizer Investigational Site Madrid Spain 28041
286 Pfizer Investigational Site San Sebastian Spain 20014
287 Pfizer Investigational Site Santiago de Compostela Spain 15706
288 Pfizer Investigational Site Sevilla Spain 41009
289 Pfizer Investigational Site Sevilla Spain 41013
290 Pfizer Investigational Site Valladolid Spain 47011
291 Pfizer Investigational Site Zaragoza Spain 50009
292 Pfizer Investigational Site Bern Switzerland 3010
293 Pfizer Investigational Site Geneve 14 Switzerland CH-1211
294 Pfizer Investigational Site Lausanne Switzerland CH-1011
295 Pfizer Investigational Site Lugano Switzerland 6900
296 Pfizer Investigational Site St Gallen Switzerland CH-9007
297 Pfizer Investigational Site Romford Essex United Kingdom RM7 OBE
298 Pfizer Investigational Site London Greater London United Kingdom E2 9JX
299 Pfizer Investigational Site London Greater London United Kingdom NW10 7NS
300 Pfizer Investigational Site London Greater London United Kingdom SW17 0RE
301 Pfizer Investigational Site Aldershot Hampshire United Kingdom GU11 3RB
302 Pfizer Investigational Site Farnborough Kent United Kingdom BR6 7AR
303 Pfizer Investigational Site Blackpool Lancashire United Kingdom FY3 8NR
304 Pfizer Investigational Site Leicester Leicestershire United Kingdom LE3 9QP
305 Pfizer Investigational Site London Middlesex United Kingdom HA8 0AD
306 Pfizer Investigational Site Coventry West Midlands United Kingdom CV1 4FH
307 Pfizer Investigational Site Coventry West Midlands United Kingdom CV2 2DX
308 Pfizer Investigational Site Swindon Wiltshire United Kingdom SN3 6BB
309 Pfizer Investigational Site Barnet United Kingdom EN5 3DJ
310 Pfizer Investigational Site Glasgow United Kingdom G11 6NT
311 Pfizer Investigational Site London United Kingdom E1 1BB
312 Pfizer Investigational Site London United Kingdom NW3 2PF
313 Pfizer Investigational Site Paisley United Kingdom P1 1HR
314 Pfizer Investigational Site

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00327691
Other Study ID Numbers:
  • 0981-117
  • A2581136
First Posted:
May 18, 2006
Last Update Posted:
May 3, 2007
Last Verified:
May 1, 2007

Study Results

No Results Posted as of May 3, 2007