Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00442845
Collaborator
(none)
2,080
121
13
17.2
1.3

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
  • Drug: Atorvastatin (Lipitor)
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ACTFAST: Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration. A Multicenter, Twelve-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Feb 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks. []

Secondary Outcome Measures

  1. Percentage of subjects achieving: []

  2. LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment. []

  3. Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment. []

  4. 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. []

  5. 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. []

  6. 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. []

  7. LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%). []

  8. 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. []

  9. Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.

  • Triglycerides up to 600 mg/dL.

  • 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
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.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00442845
Other Study ID Numbers:
  • A2581087
First Posted:
Mar 2, 2007
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021

Study Results

No Results Posted as of Feb 18, 2021