Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Study Details
Study Description
Brief Summary
Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks. []
Secondary Outcome Measures
- Percentage of subjects achieving: []
- LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment. []
- Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment. []
- Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment. []
- Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment. []
- LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata. []
- LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%). []
- The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. []
- Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
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Triglycerides up to 600 mg/dL.
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History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events
Exclusion Criteria:
- Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems, use of other drugs that would interfere with evaluation of efficacy or cause safety problems, uncontrolled hypertension, diabetes or hypothyroidism, recent cardiac event of procedure, high baseline CPK levels
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pfizer Investigational Site | Mississauga | Ontario | Cameroon | |
2 | Pfizer Investigational Site | Calgary | Alberta | Canada | |
3 | Pfizer Investigational Site | Edmonton | Alberta | Canada | |
4 | Pfizer Investigational Site | Medicine Hat | Alberta | Canada | |
5 | Pfizer Investigational Site | Red Deer | Alberta | Canada | |
6 | Pfizer Investigational Site | Campbell River | British Columbia | Canada | |
7 | Pfizer Investigational Site | Maple Ridge | British Columbia | Canada | |
8 | Pfizer Investigational Site | Nanaimo | British Columbia | Canada | |
9 | Pfizer Investigational Site | New Westminster | British Columbia | Canada | |
10 | Pfizer Investigational Site | Richmond | British Columbia | Canada | |
11 | Pfizer Investigational Site | Surrey | British Columbia | Canada | |
12 | Pfizer Investigational Site | Vancouver | British Columbia | Canada | |
13 | Pfizer Investigational Site | Vernon | British Columbia | Canada | |
14 | Pfizer Investigational Site | Victoria | British Columbia | Canada | |
15 | Pfizer Investigational Site | Brandon | Manitoba | Canada | |
16 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | |
17 | Pfizer Investigational Site | Ajax | Ontario | Canada | |
18 | Pfizer Investigational Site | Brampton | Ontario | Canada | |
19 | Pfizer Investigational Site | Burlington | Ontario | Canada | |
20 | Pfizer Investigational Site | Cambridge | Ontario | Canada | |
21 | Pfizer Investigational Site | Cornwall | Ontario | Canada | |
22 | Pfizer Investigational Site | Etobicoke | Ontario | Canada | |
23 | Pfizer Investigational Site | Mississauga | Ontario | Canada | |
24 | Pfizer Investigational Site | Niagara Falls | Ontario | Canada | |
25 | Pfizer Investigational Site | North York | Ontario | Canada | |
26 | Pfizer Investigational Site | Orillia | Ontario | Canada | |
27 | Pfizer Investigational Site | Oshawa | Ontario | Canada | |
28 | Pfizer Investigational Site | Rexdale | Ontario | Canada | |
29 | Pfizer Investigational Site | Sarnia | Ontario | Canada | |
30 | Pfizer Investigational Site | Scarborough | Ontario | Canada | |
31 | Pfizer Investigational Site | Simcoe | Ontario | Canada | |
32 | Pfizer Investigational Site | Thunder Bay | Ontario | Canada | |
33 | Pfizer Investigational Site | Toronto | Ontario | Canada | |
34 | Pfizer Investigational Site | Weston | Ontario | Canada | |
35 | Pfizer Investigational Site | Whitby | Ontario | Canada | |
36 | Pfizer Investigational Site | Willowdale | Ontario | Canada | |
37 | Pfizer Investigational Site | Chicoutimi | Quebec | Canada | |
38 | Pfizer Investigational Site | Cowansville | Quebec | Canada | |
39 | Pfizer Investigational Site | Drummondville | Quebec | Canada | |
40 | Pfizer Investigational Site | Joliette | Quebec | Canada | |
41 | Pfizer Investigational Site | Laval | Quebec | Canada | |
42 | Pfizer Investigational Site | Levis | Quebec | Canada | |
43 | Pfizer Investigational Site | Maria | Quebec | Canada | |
44 | Pfizer Investigational Site | Montreal | Quebec | Canada | |
45 | Pfizer Investigational Site | Newport | Quebec | Canada | |
46 | Pfizer Investigational Site | Pointe Claire | Quebec | Canada | |
47 | Pfizer Investigational Site | Repentigny | Quebec | Canada | |
48 | Pfizer Investigational Site | Saint Hyacinthe | Quebec | Canada | |
49 | Pfizer Investigational Site | Sainte Foy | Quebec | Canada | |
50 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | |
51 | Pfizer Investigational Site | St-georges (beauce) | Quebec | Canada | |
52 | Pfizer Investigational Site | St. Lambert | Quebec | Canada | |
53 | Pfizer Investigational Site | Thetford Mines | Quebec | Canada | |
54 | Pfizer Investigational Site | Vaudreuil | Quebec | Canada | |
55 | Pfizer Investigational Site | Saskatoon | Saskatchewan | Canada | |
56 | Pfizer Investigational Site | Quebec | Canada | ||
57 | Pfizer Investigational Site | Tricase | (le) | Italy | |
58 | Pfizer Investigational Site | Vimercate | (mi) | Italy | |
59 | Pfizer Investigational Site | Somma Lombardo | (va) | Italy | |
60 | Pfizer Investigational Site | Asti | Italy | ||
61 | Pfizer Investigational Site | Bari | Italy | ||
62 | Pfizer Investigational Site | Belluno | Italy | ||
63 | Pfizer Investigational Site | Bologna | Italy | ||
64 | Pfizer Investigational Site | Bolzano | Italy | ||
65 | Pfizer Investigational Site | Catania | Italy | ||
66 | Pfizer Investigational Site | Chieti | Italy | ||
67 | Pfizer Investigational Site | Ferrara | Italy | ||
68 | Pfizer Investigational Site | Firenze | Italy | ||
69 | Pfizer Investigational Site | Foggia | Italy | ||
70 | Pfizer Investigational Site | Grosseto | Italy | ||
71 | Pfizer Investigational Site | Napoli | Italy | ||
72 | Pfizer Investigational Site | Novara | Italy | ||
73 | Pfizer Investigational Site | Palermo | Italy | ||
74 | Pfizer Investigational Site | Perugia | Italy | ||
75 | Pfizer Investigational Site | Potenza | Italy | ||
76 | Pfizer Investigational Site | Prato | Italy | ||
77 | Pfizer Investigational Site | Roma | Italy | ||
78 | Pfizer Investigational Site | Salerno | Italy | ||
79 | Pfizer Investigational Site | San Donato Milanese | Italy | ||
80 | Pfizer Investigational Site | Sassari | Italy | ||
81 | Pfizer Investigational Site | Savona | Italy | ||
82 | Pfizer Investigational Site | Siena | Italy | ||
83 | Pfizer Investigational Site | Torino | Italy | ||
84 | Pfizer Investigational Site | Venezia | Italy | ||
85 | Pfizer Investigational Site | Hospitalet de Llobregat | Barcelona | Spain | |
86 | Pfizer Investigational Site | Girona | Cataluna | Spain | |
87 | Pfizer Investigational Site | Galdakao | Vizcaya | Spain | |
88 | Pfizer Investigational Site | Avila | Spain | ||
89 | Pfizer Investigational Site | Barcelona | Spain | ||
90 | Pfizer Investigational Site | Granada | Spain | ||
91 | Pfizer Investigational Site | Huelva | Spain | ||
92 | Pfizer Investigational Site | Jerez de La Frontera | Spain | ||
93 | Pfizer Investigational Site | Madrid | Spain | ||
94 | Pfizer Investigational Site | Marbella | Spain | ||
95 | Pfizer Investigational Site | Sevilla | Spain | ||
96 | Pfizer Investigational Site | Tarragona | Spain | ||
97 | Pfizer Investigational Site | Valencia | Spain | ||
98 | Pfizer Investigational Site | Newtonabbey | Belfast | United Kingdom | |
99 | Pfizer Investigational Site | Aylesbury | Buckinghamshire | United Kingdom | |
100 | Pfizer Investigational Site | ELY | Cambs | United Kingdom | |
101 | Pfizer Investigational Site | Peterborough | Cambs | United Kingdom | |
102 | Pfizer Investigational Site | Newtonabbey | CO Antrim | United Kingdom | |
103 | Pfizer Investigational Site | Hastings | EAST Sussex | United Kingdom | |
104 | Pfizer Investigational Site | High Valleyfield | Fife | United Kingdom | |
105 | Pfizer Investigational Site | Rutherglen | Glasgow | United Kingdom | |
106 | Pfizer Investigational Site | Leslie, FIFE | Glenrotheshire | United Kingdom | |
107 | Pfizer Investigational Site | Sunbury on Thames | Middlesex | United Kingdom | |
108 | Pfizer Investigational Site | Frome | Somerset | United Kingdom | |
109 | Pfizer Investigational Site | Barry | South Glamorgan | United Kingdom | |
110 | Pfizer Investigational Site | Doncaster | South Yorkshire | United Kingdom | |
111 | Pfizer Investigational Site | Stairfoot, Barnsley | South Yorkshire | United Kingdom | |
112 | Pfizer Investigational Site | Addlestone | Surrey | United Kingdom | |
113 | Pfizer Investigational Site | East Horsley | Surrey | United Kingdom | |
114 | Pfizer Investigational Site | Atherstone | Warks | United Kingdom | |
115 | Pfizer Investigational Site | Balsall Common | WEST Midlands | United Kingdom | |
116 | Pfizer Investigational Site | Pound Hill, Crawley | WEST Sussex | United Kingdom | |
117 | Pfizer Investigational Site | Trowbridge | Wiltshire | United Kingdom | |
118 | Pfizer Investigational Site | Chippenham | Wilts | United Kingdom | |
119 | Pfizer Investigational Site | Sheffield | Yorkshire | United Kingdom | |
120 | Pfizer Investigational Site | Bath | United Kingdom | ||
121 | Pfizer Investigational Site |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A2581087